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V4-C/6/2 



95th Congress 
2d Session 



COMMITTEE PRINT 



Committer 
»Ki.\T Xo. <>r)-r>7 



CANCER-CAUSING CHEMICALS IN FOOD 



REPORT 

together with 
SEPARATE VIEWS 

BY THE 

SUBCOMMITTEE ON OVERSIGHT AND 
INVESTIGATIONS 

OF THE 

COMMITTEE ON INTERSTATE AND 

FOREIGN COMMERCE 

NINETY-FIFTH CONGRESS 

SECOND SESSION 




DECEMBER 1978 



34^33 



U.S. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1978 



COMMITTEE OX INTERSTATE AND FOREIGN COMMERCE 

HARLEY O. STAGGERS, West Virginia, Chairman 



SAMUEL L. DEVINE, Ohio 
JAMES T. BROYHILL, North Carohiia 
TIM LEE CARTER. Kentucky 
CLARENCE J. BROWN, Ohio 
JOE SKUBITZ, Kansas 
JAMES M. COLLINS, Texas 
LOUIS FREY, Jr., Florida 
NORMAN F. LENT, New York 
EDWARD R. MADIGAN, Illinois 
CARLOS J. MOORHEAD, California 
MATTHEW J. RINALDO, New Jersey 
W. HENSON MOORE, Louisiana 
DAVE STOCKMAN, Michigan 
MARC L. 1VLA.RK3, Pennsylvania 



JOHN E. MOSS, California 
JOHN D. DIN GELL, Michigan 
PAUL G. ROGERS, Florida 
LIONEL VAN DEERLIN, California 
FRED B. ROONEY, Pennsylvania 
JOHN M. MURPHY, New York 
DAVID E. SATTERFIELD III, Virginia 
BOB ECKHARDT, Texas 
RICHARDSON PREYER, North CaroUna 
CHARLES J. CARNEY, Ohio 
RALPH H. METCALFE, Illinois 
JAMES H. SCHEUER, New York 
RICHARD L. OTTINGER, New York 
HENRY A. WAXMAN, California 
ROBERT (BOB^ KRUEGER,. Texas 
TIMOTHY E. WIRTH, Colorado 
PHILIP R. SHARP, Indiana 
JAMES J. FLO RIO, New Jersey 
ANTHONY TOBY MOFFETT, Connecticut 
JIM SANTINI, Nevada 
ANDREW MAGUIRE, New Jersey 
MARTY RUSSO, llhnois 
EDWARD J. MARKEY, Massachusetts 
THOMAS A. LUKEN, Ohio 
DO^G WALGREN, Pennsylvania 
BOB GAMMA GE, Texas 
ALBERT GORE, Jr., Tennessee 
BARBARA A. MIKULSKI, Maryland 

W, E. Williamson, Chief Clerk and Staff Director 

Kexneth J, Painter, First Assistant Clerk 

Eleanor A. Dinkins, Assistant Clerk 

William L. Burns, Printing Editor 



Subcommittee ox Oversight and Investigations 



JIM SANTINI, Nevada 
THOMAS A. LUKEN; Ohio 
DOUG WALGREN, Pennsylvania 
ALBERT GORE, Jr., Tennessee 
CHARLES J. CARNEY, Ohio 
HEV^RY 'A'.- WAXMAN, California /\ 

prflLlP.^.'SHARP, Indiana ' \S 

ANTHONY TOBY MOFFETT^ Conneclicui 
A N D R E VV M A C} U I R E , N ew Jersey ^ ', 

ROBEHt.(BO^) KRUEGER, Texas . / 

HA RLE ^O. S'^'AGGERS, West Virginia" - 
(ex ofRcio^^^Y S^ 



John E. Moss, California, Chairman 

JAMES M. COLLINS, Texns 
NORMAN F. LENT, New York 
MATTHEW J. RINALDO, New Jersey 
DAVE STOCKMAN, Michigan 
MARC L. MARKS, Pennsylvania 
SAMUEL L. DEVINE, Ohio (ex ofTnio) 






^Lowell DopoE, Oversight Task Force Director 

"Elliot A. Segal, Health Task Force Director 

^«i5lJJJ|;3Sy3*ii»rt: Choukas-Brauley, Research Assistant 

Richard Heller, Counsel 

Lester O. Brown, Special Assistant 

*' ' Pam Moruissette, Staff Assistant 

John R. Galloway, Emrgii Task Force Director 



John McElroy Atkisson, Counsel to the Subcommittee 
James L. Nellioan, Operations Director 



J. Thomas Greene, Counsel to the Chairman 



Beknaed J. V. under, Jr., Minority Counsel 
(ID 



LETTER OF TRANSMITTAL 



House of Represextatives, 
Subcommittee ox Oversight axd Ixvestigatioxs, 
Committee ox Interstate axd Foreigx Commerce, 

Washington, D.C., December 197 S^ 
Hon. Harley 0. Staggers, 

Chairman, Committee on Interstate and Foreign Commerce, 
Washington, D.C. 

Dear Chairmax Staggers: The attached report by the Subfom- 
mittee on Oversight and Investigations reviews the Federal govern- 
ment's efforts to protect the pubhc from potentially (hmgerous amounts 
of pesticide residues in food. It focuses on the activities of the En- 
vironmental Protection Agency (EPA), Department of Agricultui-e 
(USD A), and the Food and Drug Administration (FDA) with regard 
to pesticide tolerance setting, residue monitoring, and enforcement of 
statutes designed to keep unhealthy levels of pesticides from being 
deposited on or in food products. 

The Subcommittee concludes that these program.s are inadequate. 
As a result, American consumers cannot be sure that the meat, ])oultry, 
fruits, ami ve^-etables they buy are not tainted with potentially 
dangerous pesticide residues. 

We all have to eat. Because of the nature of chemical contaminants, 
we are forced to rely on the Federal government to protect us against 
potentially dangerous chemicals we cannot see, smell, or taste. Our 
examination leads us to believe that we cannot rely on the Fedei-ai 
government to protect us. 

We found for instance that E£A (1) continues to approve tolerances 
for potentially carcinogenic, mutagenic, and teratogenic pesticides 
which result in residues in or on food; (2) has set tolerances for some 
of these pesticides without complete safety data; (3) has exempted 
some potentially dangerous pesticides from its tolerance requirements 
Avhich end up in or on food; (4) uses an inadequate and outckited 
statistical base for setting tolerance levels; (5) often does not know 
what level of pesticide residue usually results from the use of a prochict; 
and (6) bases its approval of i)estici(les merely on industry-supplied 
safety data which often does not fully examine the potential hazaid 
posed by the pesticide. 

In sum, the Subcommittee concludes that EPA's tolerance setting: 
program is abysmal and needs a complete overhaul. 

Additionally, the Subcommittee is alarmed with the inadeqitatis 
monitoring and enforcement programs of USDA and FDA. The 
Subcommittee found that even when meat was found to be con- 
taminated with dangerously high levels of toxic pesticides neither 
USDA nor FDA could stop these products from reaching the dinner 
table. This is an appalling state of affairs which cannot be allowed 
to continue. 

(Ill) 



IV 

The Subcommittee recommends that these agencies move quickly 
to correct those deficient programs. The Subcommittee also suggests 
that Congress act to strengthen regulation of potentially dangerous 
pesticide products and direct these agencies to move vigorously 
to enforce the law. 

The Subcommittee further recommends that if the agencies involved 
cannot or will not take appropriate action to protect the public, then 
Congress should consider legislation to place those responsibilities 
in the hands of an agency more concerned with protecting public 
health. 

Sincerely, 

John E. Moss, 

Chairman. 



CONTENTS 



Pa?e 

Chapter I. — Introduction and methodology 1 

Chapter I L— Environmental Protection Agency's tolerance-setting program: 

1. Background 5 

2. EPA's tolerance-setting program 5 

A. Tolerance-setting methodology 8 

B. Deficiencies in EPA tolerance-setting methodology 9 

1. The tolerance-setting process and carcinogenic pesticides. 10 

2. FalUbility of the food factor 11 

3. Exemptions from the tolerance-setting requirement 14 

a. Other deviations from standard tolerance-setting 17 

3. Summary of subcommittee findings and conclusions concerning 

E PA tolerance-setting 18- 

4. Subcommittee recommendations concerning EPA tolerance-setting. 20 
Chapter III. — U.S. Department of Agriculture — Chemical residue moni- 
toring of meat and poultry: 

1. Background 23 

2. USDA's monitoring programs for chemical residues in meat and 

poultry 23 

A. USDA's random sample monitoring program 25 

B. Food and Drug Administration foilowup 26 

C. Animal drugs 26 

D. USDA pretest program 28 

3. Subcommittee findings and conclusions 29 

4. Subcommittee recommendations 29 

Chapter IV. — Food and Drug Administration — Chemical residue moni- 
toring of foods other than meat and poultry: 

1. Background 31 

2. Food and Drug Administration surveillance system for chemical 

residues in foods other than meat and poultry 31 

A. FDA residue-monitoring program 32 

B. "Market basket" program 34 

3. FDA foilowup of USDA monitoring program 35 

4. Subcommittee findings and conclusions 36 

5. Subcommittee recommendations for improving Food and Drug 

Administration regulatory programs concerning chemical residues 

in food 37 

Chapter V. — General conclusion 39 

Separate views of Hon. James M. CoUins, M.C 43 

APPENDIXES 

I. List of 36 randoml}^ sampled pesticide chemicals and data lacking 

for them (safety) 45 

II. RPAR's issued as of April 17, 1978 49 

III. List of foods EPA assum.es consumers eat no more of than 7.5 oz. 

per year 61 

IV. Potomac research report on inert ingredients, (excepts) 62 

V. List of pesticides suspected of causing tumors 77 

VI. FDA's regulatory actions involving chemicals in food 78 

VII. Letter from GAO to subcommittee about FDA's total diet study__ 85 
VIII. Animal drugs and pesticides which may leave residues in food and 

which ones are monitored 88 

IX. Liverstock chemical violation rates found by USDA 96 

X. Animal drugs and pesticides suspected of causing cancer or brith 

defects 98 

XL Glossary of terms 101 

(V) 



CANCER-CAUSING CHEMICALS IN FOOD 



Chapter I. — Ixtroductiox and Methodology 

On February 14, 16, and 24, 1978, the Subcommittee on Oversight 
and Investiiiations of the Interstate and Foreign Comm.erce Com- 
mittee held hearings concerning cancer-causing chemicals in food. The 
hearings and concurrent Subcommittee investigation, which extended 
from October of 1977 through August of 1978, explored the shared 
responsibilities of the Environmental Protection Agency (EPA), the 
Food and Drug Administration (FDA), and the United States Depart- 
ment of Agriculture (USD A) in regulating toxic chemicals in food. 

The hearings and investigation were part of a series of Subcommittee 
inquiries into the effectiveness of federal regulatory programs designed 
to reduce consumer exposure to cancer-causing substances. Over the 
past two and a half years the Subcommittee has examined problems 
associated with Nitrosamines, ^ Carbon Tetrachloride contamination 
of drinking water, ^ Polybrominated Biphenyls (PBB's),^ chemicals 
in hair dyes and cosmetics'* the use of the flame retardant, Tris, in 
children's sleepwear,^ cigarettes,® and, most recently, the disposal of 
hazardous wastes. ^ 

During the course of its investigation into environmental causes of 
cancer, the Subcommittee has examined federal statutes governing 
regulation of toxic chemicals that are administered by the Environ- 
mental Protection Agencv (EPA), National Institute of Occupational 
Safety and Health (NIOSPI), Food and Drug Administration (FDA), 
U.S. Department of Agriculture (USDA), Occupational Safety and 
Health Administration (OSHA), and Consumer Product Safety 
Commission (CPSC). 

During its investigation into cancer-causing chemicals in food, the 
Subcommittee reviewed hundreds of EPA, FDA and USADA files, 
worked closely with the General Accounting Office (GAO) to assess 
federal programs desigTied to regulate toxic substances in food, and 
reviewed all relevant federal statutes and regulations. 



1 "Environmental Causes of Cancer," hearings before the Subcommittee on Oversight and Investigations 
Committee on Interstate and Foreign Commerce, U.S. House of Representatives, 94th Cong., 2d sess., ser 
No. 94-141. 

2 "Carbon Tetrachloride Contamination of Public Drinking Water," hearings before the Subcommittee 
on Oversight and Investigations, Committee on Interstate and Foreign Commerce, U.S. House of Repre- 
sentatives, 95th Cong., 1st sess., ser. No. 9.5-29. 

3 "Adverse Effects of Polybrominated Biphenyls (PBB's)," hearings before the Subcommittee on Over- 
sight and Investigations, Committee on Interstate and Foreign Commerce, U.S. House of Representatives, 
95th Cong., 1st sess. ser. No. 9.5-85. 

^ "Cancer-Causing Chemicals— Part I: Safety of Cosmetics and Hair Dyes." hearings before the Sub- 
committee on Oversight and Investigations, Committee on Interstate and Foreign Commerce, U.S. House 
of Representatives, 95th Cong. 2d sess., ser. No. 9.5-91. 

^ "Regulation of Cancer- Causing Flame- Retardant Chemicals and Governmental Coordination of Test- 
ing of Toxic Chemicals (Tris)." hearings before the Subcommittee on Oversight and Investigations, Com- 
mittee on Interstate and Foreign Commerce, U.S. House of Representatives, 95th Cong., 1st sess., ser. No. 
95-33. 

« "Cigarette Smoking and Health," hearings before the Subcommittee on Oversight and Investigations, 
Committee on Interstate and Foreign Commerce, U.S. House of Representatives, 95th Cong., 2d sess., 
Oct. 5 and 6, 1978. 

^ "Federal Implementation of the Resource Conservation and Recovery Act," hearings before the Sub- 
committee on Oversight and Investigations, Committee on Interstate and Foreign Commerce, U.S. House 
o IRepresentatives, 95lh Cong., 2d sess. Oct. 30, 1978. 

(1) 



2 

The Subcommittee learned that, despite federal programs desio^ned 
to protect the public from harmful chemicals, virtually all food con- 
sumed in this country contains residues of synthetic substances that 
have been developed in recent decades. Scores of these chemicals have 
lately been linked to cancer, birth defects and permanent genetic 
mutations. Still others have never been tested for safety. 

Pesticides are a ubiquitous source of chemical residues in food. Two 
hundred seventy-one pesticides are registered for agricultural use in the 
United States. Forty-one cancer, genetic mutations, birth defects and/ 
or reproductive disorders. Another 92 lack safety studies for these 
serious injurious effects. Yet, they continue to be sold and widely 
used under the direction of federal regulatory programs. 

The Subcommittee's hearings and investigation focused on pesti- 
cides and two other groups of chemicals that are detected as residues 
in food during government monitoring: 

1. Pesticides (literally ''pest killers") include herbicides (weed 
killers), fungicides (mold, mushroom, mildew, and rust destroyers and 
repellants) and insecticides (insect killers). Modern agriculture de- 
pends on the use of pesticides. Unfortunately, pesticides, which rou- 
tinely remain as residues in finished produce, are often toxic to 
animals and humans as well as to the pests they are formulated to 
destroy. Residues of pesticides are consistently found in samples of 
human blood, urine and milk. 

2. Animal drugs, such as antibiotics and sulfa drugs, are routinely 
administered to livestock to prevent the spread of disease and, in some 
cases, to promote growth. Animal drugs are the most frequently de- 
tected chemical contaminants in meat and poultry. This report explains 
ways in which animal drugs are carelessly and intentionally abused. 
While the effects of these drugs on human health have not been well 
researched, the report explores their known and susi)ected hazards. 

3. Industrial contaminants can adulterate food although they are 
not applied directly on crops or fed to livestock. For example, indus- 
trial pollution of water can result in contaminated fish. 

Chapter II is a discussion of the Environmental Protection 
Agency, which is entrusted with the responsibilit}^ of approving 
pesticides for use. Under the terms of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), the EPA establishes pesticide tolerances for 
raw agricultural commodities (maximum amounts of active pesticide 
ingredients that may be legally present in or on particular foods and 
animal feeds). Tolerance-setting under the FFDCA is a prerequisite 
of pesticide registration — or licensing for use — under the Federal Insec- 
ticide, Fungicide and Rodenticide Act (FIFRA). The pesticide regis- 
tration system is also in EPA's jurisdiction. EPA has the authority to 
prosecute violators of pesticide use laws. 

Chapter III is a discussion of the U.S. Department of Agriculture's 
regulatory responsibilities concerning chemical residues in food. 
USDA conducts two residue monitoring ])rograms for toxic sub- 
stances in edible animal tissues. USDA's random sample monitoring 
program analyzes tissue sami)les from a i)erccntage of randoml}^ se- 
lected animal carcasses in slaughterhouses. The USD A pretest program 
enjoins growers who have shipped animals with above-tolerance levels 
of pesticides (as established by EPA) or animal drugs (animal drug 



tolerances are set by FDA) to market in the ])ast, to provide the de- 
partment with laboratory analyses of livestock samj)les prior to 
slaughter. USDA and FDA share responsibility under the FFDCA, 
the Federal Meat Inspection Act, and the Poultry Products Insi)ec- 
tion Act to ])revent ''adulterated" (chemically contaminated) meat 
and poultry from enterin<j: interstate commerce. USDA refers violations 
to the FDA for j)ossible })rosecution. 

The Food and Drug Administration, under the terms of the FFDCA, 
monitors foods other than meat and j)oultry for chemical residues. 
FDA, as described above, has the authority to prosecute growers 
whose animals have been found violative during USDA monitoring. 
Chapter IV deals with the regulatory programs of the FDA. 

Specific subcommittee findings, conclusions and recommendations 
are presented at the close of each chapter. 

General findings and conclusions are stated in chapter 5. 

In his statement that opened the first day of hearmgs on February 
14, 1978, Subcommittee Chairman John E. Moss (D. CaL), offered 
this assessment of the problem of toxic substances in food : 

Chemical contamination of food presents an insidious hazard because chemicals 
are almost impossible for the consumer to detect. He cannot see, smell, or taste 
them . . . Unhide some other environmental hazards, the consumer has no 
freedom of choice when it comes to toxic residues in food.^ 

We all have to eat. And because of the nature of chemical con- 
taminants, we are forced to rely on the federal government, with 
its staff, facilities and legal authority, to protect us against poten- 
tially dangerous chemicals Ave "cannot see, smell, or taste.'' As this 
report will illustrate, current government programs and laws are 
not providing us with adequate protection from the known and un- 
known hazards of chemically contaminated food. 

s "Cancer-Causing Chemicals— Part 2: Chemical Contamination of Food," hearings before the Suhcom- 
mittee on Oversight and Investigations of the Committee on Interstate and Foreign Commerce of the 
U.S. House of Representatives, 95th Cong. 2d sess. serial No. 95-118 (hereinafter cited as Hearings.) 



Digitized by the Internet Archive 
in 2013 



http://archive.org/details/cancercausingcheOOunit 



Chapter II. — The Environmental Protection Agency's 
Tolerance-Setting Program 

1. background 

In 1970, the newly created Environmental Protection Agenc}^ (EPA) 
inherited all responsibility for approving pesticides for use in the 
United States: 

Pesticide tolerance setting functions, governed by tlie Federal 
Food, Drug, and Cosmetic Act (FFDCA) ^ of 1938, were trans- 
ferred from the Food and Drug Administration (FDA) to the 
EPA. 

The pesticide registration system, administered under the Fed- 
eral Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 
1947, was moved from the United States Department of Agricul- 
ture (USD A) to the EPA. 
According to the ' 'pesticide amendment", added to the FFDCA in 
1954, pesticide tolerances (maximum amounts of active pesticide in- 
gredients that ma}^ be legally present in or on particular foods) are 
to be set *'to the extent necessary to protect the public health." A 
separate tolerance must be established for each raw agricultural com- 
modity on which the pesticide ^vill be used. The establishment of a 
tolerance, or an official exemption from the tolerance requirement, is a 
prerequisite of pesticide registration (licensing for use) under FIFRA. 
Tolerances are set and registrations are granted by the Registration 
Division of EPA's Office of Pesticide Programs (OPP). 

This chapter will explore the Environmental Protection Agency's 
tolerance setting system governed by the FFDCA. Registration pro- 
grams under FIFRA will be discussed as they relate to tolerance 
setting. The chapter will conclude with a summary of the Subcom- 
mittee's findings and its recommendations for programmatic and 
legislative changes. 

2. epa's tolerance-setting program 

Five thousand nine hundred and eighty four individual tolerances 
have been set for 271 pesticides since section 408, '^the pesticide amende 
ment", was added to the Federal Food, Drug, and Cosmetic Act in 
1954. Nine hundred and forty of the tolerances that have been estab- 
lished over the years are for pesticides now believed to be potential 
carcinogens (cancer causers). Many other tolerances remain in effect 
for pesticides that have never been tested for their potential to cause 
cancer, birth defects, sterility or genetic mutations. 

• Federal Food, Drug, and Cosmetic Act, as amended. 21 U.S. C. 34Ga(b). [FFDCA Section 408(b) .] 

(5) 



6 

The following table lists the 3^ears in which various safet}^ tests were 

first required by the government before a pesticide tolerance would 

be granted: 

Testing requirements 

Date fust 
required 

Acute toxicity (adverse effect? from a single dose. Mortality in 50 percent 

of the animals exposed) 1954 

Subacute toxicity (adverse effects from repeated exposure over a short pe- 
riod of time, usually 90 days) 1954 

Chronic feeding-oacogenicity i° (chronic feeding over most of test animals' 

lifetimes to determine whether substance induces growth of tumors) 1963 

Reproduction (testing to determine whether substance causes adverse ef- 
fects on animals' abilities to reproduce: size and health of offspring;, 
effects on fertility, etc.) _"_ 1963 

Teratogenicitv ^^ (testing to determine whether a substance causes birth 

def ects) _ _ _" 1970 

Mutagenicity ^' (testing to determine whether substance causes genetic 

changes that will be passed on to future generations) i^ 1970 

As the table illustrates, prior, to 1963 jjesticides werej^nly tested 
for their highly apparent short-range toxic effects before tolerances 
were established by the government. During the sixties, tests for 
oncogenicity (ability to induce tumors) and tests to determine effects 
on reproduction were added. It wasn't until less than a decade ago 
that the government began to concern itself with a pesticide's power 
to cause birth defects and permanent genetic mutations. 

In a 1975 review that preceded a report to Congress entitled 
^Tederal Pesticide Kegistration Program: Is It Protecting the Public 
and the Environment Adequately from Pesticide Hazards?" the 
General Accounting Oihce (GAO) randomly selected 36 pesticide 
chemicals with established tolerances to determine the availability 
of safety data. Of the 36: 

Seven lacked cancer and reproduction studies, 
Fourteen lacked birth defect studies, and 
Twenty-three lacked mutation studies.^"* 

The GAO also reviewed the adequacy of residue (the amount of a 
pesticide remaining in or on food following normal product use) data 
for existing tolerances. 

Mr. Henry Eschwege, Director of the Community and Economic 
Develoj)ment Division of the GAO, testified to the importance of 
setting tolerances based on realistic resi(kie data cUiring the hrst ch\y of 
Subcommittee hearings on February 14, 1978: 

Tolerances set at artificially high levels may subject the public to greater than 
necessary residues in food. Tolerances set l^elow the residue level expected from 
proper apphcation of the pesticide may result in excessive residues which would 
render the food adulterated, and sul)ject to FDA removal from interstate 
commerce. 15 

In other words, a tojerancejevel tliat is higher than neaessary could 
create a'needless public health risk while a level that is unrealistically 
low could result in illegal residues stemming from normal product use. 

'0 OncoRenicity is defined as the power of a substance to incite tumor fonnalion, either benign or malignant, 

" Teratogeniiity is defined as the ability of a substance to induce birth defects by acting on the embryo, 

'» Mutagcnicily, defined as tlie power of a substance to produce permanent, hereditary genetic changes. 
Genetic mulaliuns may not be apparent for generations. x .,,....._ ., ^.. 

'3 Cieneral Accounting Office Rei)ort, "Federal Pesticide Registration Program: Is it Protecting the Public 
and the Environment Ade(iuately From Pesticide Hazards?" Washington, D.C.: Dec. 4, 1975, pp. 7-8. 
<Text parai)hrased hero.) 

>* Ihid, p. ». 

'5 Ilearingn, supra n. 8. p. 5. 



In the 1975 review, GAG studied residue data for 10 common crops 
("including apples, peaches and beans) for which 143 tolerances had 
been established. GAO determined that 91 of the 143 tolerances lacked 
residue data altogether and that, 

Of the remaining 52 tolerances established, only 6 accurately reflected avail- 
able residue data, 27 were set above and 11) were set below residues remaining 
on crops." 

The nature of these findings, coupled with the EPA's apparent 
inability to deal effectively with cancer-causing pesticides and safety 
test data gaps, led the GAO to conclude that it was time for EPA to : 

Review the adequacy of supporting safety and residue data for all existing 
tolerances and require manufacturers to submit missing data.^^ 

EPA responded on September 11, 1975 : 

GAO's criticisms are well-founded, and we are very much concerned about 
tolerance-setting problems. In the recent past our emphasis on the implementation 
of FIFRA has allowed for insufncient attention to problems identified here. Now 
that the necessary regulations for registration have been promulgated, we can 
turn more of our attention to review of the tolerance regulations and procedures, 
to reassessment of tolerances alread}^ regulated, and to a comprehensive evaluation 
of the whole scientific l)asis for tolerance setting. We accept and will implement 
GAO's recommendations in this area.^'^ [Emphasis added.] 

In November of 1977 the Subcommittee asked the General Account- 
ing Office to conduct a follow-up study to assess the adequacy of 
actions taken in response to the (1975) recommendations respec ting- 
tolerance setting and residue monitoring. 

The GAO follow-up study of EPA's tolerance setting program 
(FDA's monitoring system was also included in the leview), was 
completed in early 1978 at the request of the Subcommittee. At the 
hearings in February GAO testified that: 

1. Safety test and residue data gaps still exist for pesticides with 
established tolerances. EPA has failed to officially notify registrants 
that they will be required to supply missing data by any given date. 

In February of 1978, EPA published a listing in the Federal Register 
of 442 registered pesticides which lacked safety studies that irould require 
over tiro years to complete. As of February 1978, EPA had not directed 
registrants to begin these studies. 

2. EPA has deviated from its own m.ethod of computing safety levels 
for pesticides in certain instances. EPA computes the acceptable daily 
exposure for residues of each pestfcide. The agenc}^ then determines 
the total potential daily exposure based on all tolerances that have 
been set for that pesticide and an average daily diet estimate for an 
American male. If the total pesticide residues likel}^ to be found in the 
daily diet are below the acceptable daily exposure, tolerances estab- 
lished for that pesticide are considered safe. However, the GAO follow- 
up study found cases in which the total potential daily exposure ex- 
ceeded the acceptable daily exposure. For instance, potential public 
exposure to toxaphene — a suspect carcinogen — was almost four times 
the acceptable daih^ exposure computed by the EPA. 



16 Hearings, supra note 8, p. 5. See also GAO Report, "Federal Pesticide Recistration Program: Is it 
Protectins; the Public and the Environment Adequately From Pesticide Hazards?" (Hereinafter cited as 
GAO Rfvort.) pp. 42-43. 

1" GAO Report supra note 16, p. 48. 

18 GAO Report supra note IG, p. 83. 



8 

3. Some registered pesticides have resulted in residues in food for 
which no tolerance has been set. For example, some uses of chlordane 
have resulted in residues in milk, while no milk tolerance has been 
established for chlordane. ^^ 

Overall, the GAO found that EPA had made "little tangible 
progress" ^° in reviewing and improving its tolerance setting program 
in the two 3^ears since it agreed to accept and implement GAO's rec- 
ommendations.^^ Mr. Eschwege pointed to onh^ two agenc}^ measures 
which demonstrated progress in improving EPA's system of approving- 
pesticides for use: 

First, EPA has requested that its Science Advisory Board "study 
the scientific foundations of the entire tolerance setting program." -^ 
While this is the only tangible progress EPA has made that is directly 
related to tolerance i)rogram reform, waiting for advisory board 
recommendations can actually have the effect of impeding needed 
change. 

Second, on Juh^ 3, 1975, EPA instituted a program entitled "Rebut- 
table Presumption Against Registration" (RPAR). Under the RPAR 
program, the reregistrations of pesticides that are known to cause 
cancer or other serious ill effects are being scrutinized. 

However, only pesticides with known hazards are being reviewed — 
just seven of the 36 chemicals GAO studied in 1975 and found lacking 
in 44 recjuired safety tests. 

The EPA is far behind its projected RPAR schedule. In April 
of 1976, EPA jniblished a list of 45 chemicals that would be subjected 
to RPAR proceedings. Final decisions on all 45 chemicals were to be 
made by October of 1977. However, as of April 17, 1978, only one 
RPAR proceeding had been completed. 

Finalh, while an RPAR proceeding may lead to an EPA decision 
to deny or cancel registration of a pesticide, the registration system 
is atlministered under FIFRA rather than FFDCA. Decisions made 
under FIFRA do not directty affect the tolerance setting system. For 
instance, tolerances cannot be revoked under the ])rovision of FIFRA. 
Thus, food products containing residues of cancelled pesticides (regis- 
tration denied) can be legally sold as long as pesticide tolerances have 
not been revoked under the FFDCA. 
A. Tolerance-setting methodology 

Whenever an applicant seeks registration for pesticide use, he or 
she is required by EPA to simultaneously apply for a tolerance or an 
exemption from the tolerance requirement for each commodity in 
which residues of the substance could I'omain. On Feb. 14, 1978, Steven 
Jellinek, Assistant Achninistrator for Toxic Substances at the EPA, 
ex])iained the i)rocess that triggers tolerance-establishment: 

The petitioner — usually the manufacturer of the pesticide in cjuestion — proposes 
to EPA a specific tolerance level for the crop or ci'oi)s on ^^hich the j^roduct 
is to be applied. The petiti(»n is hacked up by two basic kinds of ii>forn,ation: 
first, chemistry data, showinji; actual residues after application, how the ch(>nucal 
behaves on the commoditv, and the nature of the pesticide breakdown products, 
as well as the analytical liiethodology foi- detecting residues; and second, toxicol- 
ogy data, showing the effects of tlie chemical on test animals." 

w lUarlngs, supra note 8, p. 0, opcniiiK slatcnioiit of Uciuy Kschwofjo, (u'lioial Ac-counlinp OfTice. 

» ll(arings, supra note 8, p. *•>. 

« Ibid. 

« Ihid, p. 5. 

» Ibid, p. 30. 



9 

EPA then sets the tolerance according- to two basic princi])les| 
that it protect the piibhc health, and that it be set at a level no hi^^her 
than is necessary to control the i)est. EPA's Office of Pesticide Pro- 
grams uses the toxicology data provided by the manufacturer to test 
the product for a safe tolerance level according to standard agency 
methodology. Potential exposure to the substance is compared with 
maximum i^ermissihle exposure. Permissible exposure is calculated in 
the following manner: 

1. No Observable Effect Level (NOEL), defined as the 'level of a 
substance administered to a group of experimental animals at which 
those [adverse] effects observed or measured at hio'her levels are 
absent. ..." Test animals used are usually rats or mice. The NOEL 
for test animals is expressed in ])arts ])er million (ppm). Parts per 
million are then converted to milligrams per kilogram of body weight 
per day (mg/kg/day). 

2. Safety Factor or ''Factor of lOOr The NOEL in mg/kg/body 
weight/day is divided by the Safety Factor, usually a factor of 100 
because, according to the EPA, ''man appears to be 10 times as sensi- 
tive to toxic substances as the rat and . . . sickness increases the 
susceptibiHt3^ of man to such substances 10 times." 

.3. Acceptable Daily Intake (ADI). The ADI is the quotient obtained 
when the NOEL is divided by the Safety Factor. 

4. The Maximum Permissible Intake {MP I) is determined by multi- 
])lying the Acceptable DaiW Intake b}^ what the EPA characterizes as 
the average weight of an adult, 60 kilograms (132 pounds). 

The Maximum Permissible Intake (permissible exposure) is then 
compared with the Theoretical Maximum Residue Contribution 
(maximum potential exposure) which is determined in the following 
way: 

(a) The Tolerance proposed by the applicant for pesticide 
registration is multiplied b}^ 

(6) The Food Factor, which is an estimate of how much of the 
commodity to be treated with the pesticide will be eaten daily 
by the average American. 

(c) This product is then multiplied by the Daily Diet, which 
EPA estimates to be 1500 grams (3.3 pounds). 

{d) The Proposed Tolerance X the Food Factor X the Daily 

Diet = the Theoretical Maximum Residue Contribution (TMRC). 

If the Theoretical Maximum Residue Contribution does not exceed 

the Maximum Permissible Intake, then the proposed tolerance is 

considered to be a safe one according to EPA's methodology. 

If multiple tolerances are proposed for a single pesticide ingredient, 
the EPA totals the Theoretical Maximum Residue Contributions 
for all commodities on which pesticides w^ill be applied and then 
compares the sum with the Maximum Permissible Intake. The total 
TMRC's for any given pesticide must not exceed its MPI. 

B. Deficiencies in EPA tolerance-setting methodology 

There are many problems associated with the tolerance setting 
process. As we said earlier, EPA does not always apply its tolerance- 
setting methodology uniformly. However, even flawless adherence to 
the system would fall far short of i)roviding the public with adequate 
protection from harmful pesticides. 



10 

1. THE TOLERANCE-SETTING PROCESS AND CARCINOGENIC PESTICIDES 

At least 25% of all pesticides on the market have shown cancer- 
causing potential. ^^ As the Subcommittee pointed out in October 1976, 
more than 80% of those 23 S active ingredients (which represent 
approximately one-third of all pesticides on the market in 1976) 
meeting or exceeding the risk criteria are suspect carcinogens. One- 
sixth of the established tolerances are for carcinogenic pesticides. 

Yet EPA's Steven Jellinek told the Subcommittee on Februarv 14, 
1978: 

The basic system for establishing tolerances has been in place for some twenty 
years now. As we learn more and more about pesticide hazards, areas of uncer- 
tainty in the s^'stem become apparent. For instance, the system is inappropriate 
for dealing cleanly with pesticides for which no safe level of exposure can be 
determined, those of a potential carcinogen, for example.^^ 

Mr. Jellinek was not the first EPA official to admit that the tolerance 
setting process is inappropriate for carcinogens. The toleiance setting 
methodology pivots on the No Observable Effect Level (NOEL) 
concept. The NOEL is the amount of a pesticide dose which does 
not produce any adverse effects in test animals. On June 30, 1977, 
Andrew M. Breidenbach, former Special Assistant to EPA Adminis- 
trator Douglas M. Costle, told the Senate Agriculture Research 
and General Legislation Subcommittee: 

"The existing tolerance setting system, based on the establishment of a NOEL, 
has not been designed to handle pesticide residues for which no safety threshold 
can be dettrmined. The question then arises whether a tolerance should be set 
for a pesticide which is a potential carcinogen, for example, since it is not possible 
to establish a NOEL for such a substance." ^6 

The answer to this question is — ''no, tolerances should not be 
established for potential carcinogens". Then what about the 940 
tolerances representing a third of all pesticides, which are suspect 
carcinogens and have tolerances? These tolerances should be immedi- 
ately reassessed. 

However, tolerance reassessment is a low j^norit}^ at the EPA. 
The as^encv's pesticide programs operate on an annual buduet of 
$60.7 million (FY 1979) with an allotment of 1,013 positions. Not 
one of these positions is devoted exclusively to tolerance reassessment. 
The EPA told the Subcommittee on February 14: 

Several proposals for tolerance reassessment of different levels of effort were 
made in the FY 77 budget process. Two positions were finallj^ allotted for tol- 
erance reassessment. These positions were not filled, however." 

In defense of its lack of action with respect to tolerance reassess- 
ment, the EPA points to its RPAR }H*oceedings and its proposed re- 
registration system. ^^ EPA says the rercgistration elTort may take 
fifteen years to com])lete,^^ and we have already said that the RPAR 
program is behind sche(hde. Both RPAR and pesticide registration 
are administered under the Federal Insecticide, Fungicide and Ro- 



2< Sop report by the Subcommittep, on Oversight and Invpstigations, "Fodpral Rppiilation and Regulatory 
Reform," U.S. (Jovpnimont Printing OfTice, Washington, D.C., October liiTO, p. 142. 

2' IIearin(is, supra, note H, p. .31. 

»• Statement of Andrew \V. Breidenhaeh, Special Assistant to the Administrator, Environmental Pro- 
tection Agency, before the Agricn'.tiiral Research and (Jenera! Legislation Subcommittee of the Committee 
on Agriculture. Nutrition and Forestry, U.S. Senate, June 30, 1977. 

-'' Hearings, supra, note 8, p. 6g. 

ii Ibid, p. 31 ;J2, 

2« Ibid, p. 82. 



11 

(lenticicle Act, which is not as striii^j^mtly protectiv^e of hurniri health 
as the Federal Food, Dru^, and Cjsrn3tic Act, which governs the 
tolerance s^^stem. As Mr. JelUnek explained to the Subcommittee: 

FFDCA speaks to "safe for human consumption." FIFRA demands that EPA 
balance risks and benoiits in reaching decisions that a pesticide does not cause an 
unreasonable adverse effect in humans or the environment.^" 

EPA clearly supports a trend away from the strictly health-oriented 
languag-e of the FFDCA, toward the less strin<2:ent health-related 
])rovisions of FIFRA, as is evident from the February 14 hearing- 
record. Mr. Jellinek testified : 

I think what I said is that we've decided as an agency to make these basic 
decisions under FIFRA and to accompany that decision with a decision on the 
tolerance.5^ 

Therefore, the only action EPA has taken publicly that relates 
directly to tolerance setting as defined by the Federal Food, Drug, and 
Cosmetic Act, is the agency's request to its Science Advisory Board 
to review the tolerance system and make recommendations. EPA 
says it expects a draft of this recommendation by the end of 1978.^^ 

2. lALLIBILITY OF THE FOOD FACTOR 

The "Food Factor" is an important element of the tolerance setting 
mechanism. In determining the Food Factor, EPA relies on data 
gathered by the United States Department of Agriculture during the 
1960's and printed in USDA's report series entitled, ''Consumption 
of Food m the United States." '' 

With few exceptions, USDxl consumption data used by EPA are 
based on simple division: the total yield of a given commodity is 
divided by the population of the United States. EPA then divides the 
quotient calculated by the USD A by the number of days in a year 
to obtain the amount of per capita daily consumption known as the 
Food Factor. 

This system is fallible because it averages consumers of a particular 
food with non-consumers. According to a Library of Congress report 
on the consumption statistics EPA uses in esablishing tolerances: 

It is well known that the per capita consumption of many foods varies con- 
siderably from person U> person. Income and household size are two important 
factors which affect the amounts c^f individual foods consumed per person. Age, 
sex, region of the country, food preference, season of the year, and farm or non- 
farm residence are other factors that affect the amount of each food a person eats.^* 

For instance, using consumption data from a USD A 1965-66 house- 
hold survey, only one in twenty families consumes fresh pears. Since 
EPA's official Food Factor is based on average consumption for the 
total population, the amxOunt of pears actually consumed by an in- 
dividual may be underestimated by as much as 2,000 percent. 

30 Ibid, p. 32-33. 

3' Ibid p. 88. 

32 Ibid. 

'3 U.S. Department of Agricultural Research Service, "Household Food Consumption Survey 1965-6(»" 
See Reports. Nos. 1, n, n, and 12. 

34 Library of Congress Congressional Research Service, "Considerations in the Use of USDA Food Con- 
sumption Statistics in the setting of Pesticide Toleran.-es by the Envircnmenial Protection Agency," a 
report prepared at the request of the Subcommittee on Oversight and Investigations, Feb. 13, 1978, p. 2. 



34-433—78- 



12 

EPA assumes that no more than 7.5 ounces of the following foods 
are consumed per person per year: 

Artichokes, Eggplant, Mollasses, Safflower, 

Avocados, Figs, Mushrooms, Summer Sqnash, 

Barley, Honeydew Melons, Nectarines, Swiss Chard, 

Biack-eyed Peas, Hops, Okra, Tangelos, 

Coconut, Horseradish, Plums, Tangerines, 

Crabapples, Kale, Radishes, Turnips, 

Cranberries, Mangoes, Raspberries, Walnuts, 

Dates, Millet, Rye, Winter Squash.^ 

These levels border on the absured, as Lowell Dodge, Counsel to the 
Subcommittee, pointed out during the hearings: 

. . . you only need to eat 7.5 ounces of avocado [per year], for instance — about 
the amount of avocado that is contained in a single avocado — before you begin to 
exceed the level that EPA assumes as the usage level in setting up tolerances. ^^ 

Mr. Dodge went on to cite other examples of distorted annual per 
capita consumption statistics used by the EPA: seven and one-half 
ounces of brussel sprouts; seven and one-half ounces of tangerines 
(about two fruits). For actual consumers of these goods, amount 
of consumption is much higher. 

Perhaps the most frightening ramification of EPA's faulty system 
for computing the Food .Eaato i' involves infant consumption of milk. 
Infants uncler the age of one consume twice as much milk as the 
average individual. A tolerance level that is based on a figure that 
underestimates consumption by one-half, and is computed using the 
average vreight of an adult (132 pounds), is hardly adequate for infants. 

The EPA claims that, ''When a proposed milk tolerance is revised, 
the TMRC (Theoretical Maximum Residue Contribution) is calcu- 
lated for infants in particular, averaging a total milk diet."^' Plow- 
ever, several toxicologists in EPA's Toxicology Branch of the Registra- 
tion Division Office of Pesticide Programs, admitted during a sub- 
committee staff surve}^ that they do not routinely consider high con- 
sumption of milk by infants in setting milk tolerances. ^^ 

EPA officials admit that milk may warrant more special attention 
to safety testing and tolerance setting than it is presentl}' ac- 
corded. In a memo dated January, 1978, entitled ''Milk Tolerances", 
Mr. Edwin L. Johnson, Deputy Assistant Administrator of EPA's 
Office of Pesticide Programs, wrote: 

Milk, as a prime food for infants and children, an important item in the diet of 
pregnant and lactating women, and a component of the diet of millions of con- 
sumers throughout their life span, may deserve special handling. . . .^» 

Mr. Johnson went on to sa}^: 

Because the fetus and the neonate [newborn] are at a spcu-ial risk, due to imma- 
turity of body structures and functions, special studies which may fenture Hfetiine 
exposure, beginning l)efor<^ c()ncei)tion; studies in which exposure begins at birth; 
and special reprochiction and teratologic studies may be needed to support safety 
of milk additives, including pisticides.'*" 



"Pee App. III. 

38 IleaTiags. supra note 8, p. 89. 

37 Pud, p. IS. 

3s Survey condnctod by subcommittoo staff in Fob. 1078. 

3" llearinns Huprn nolo 8. p. .")7, nionio enlillod "Milk '"I'olorancps" fnni: p:dwin L. .Tohnson, Deputy As- 
sistant Adnii'nislralor, ETA. Ollicc of I'esLicide rrograras, to: Dr. Norton Nelson, Chairman EPA Environ- 
mental Health Advisory Coramittoe. 

<" Ihid, p. 08. 



13 

The memo on milk tolerances has been submitted to EPA's Science 
Advisory Board for its overall review of the tolerance s^'.^tem. The 
Board is expected to make recommendations concernin<^ milk toler- 
ances and other EPA tolerance setting policies following its review. 

The Librar}^ of Congress report on consumption data suggests: 

EPA could better identify groups of consumers with hijih potential intakes of 
pesticide residues by basing its calculations on a high level of food consumption 
rather than on averages. ''^ 

The Library of Congi'ess report goes on to say that USDA statistics 
are available to the EPA that identify high level consumption groups 
by age and sex. For example, according to 1965-66 statistics, high 
consumption gToups include : 

Males 15-17 years for cream, ice cream, bread, rolls and biscuits; males 18-19 
3^ears for pork and some baked goods; males 20-34 for beef, eggs, poultry, pota- 
toes and tomatoes; males 35-54 for dark green vegetable mixtures; females 55- 
64 for citrus fruits; and males and females under one for milk.''^ 

Nevertheless, these figiu^es still treat consumers and non- consumers 
alike. If non-consumers of particular foods in each age-sex group were 
to be excluded, the figures would more accurately reflect actual con- 
sumption levels. Again, the Library of CongTess report states: 

The highest reported consumption of fish and shellfish is 18 grams per person 
per day for males 55-64 3'ears, 80 pe'cent more than the average for all inrlivid- 
uals. However, only 10.8 percent of the males in this age group reported eating 
fish and shellfish. Thus, the average consumption of those persons actually eating 
fish and shellfish is several times the reported average. It is on the order of 167 
grams per day.'*^ 

In 1977, when the EPA revised the ''action levels" (legal amounts 
of chemical residues that may be present in foods for which no toler- 
ances have been established) for the pesticide Kepone in seafood, the 
agency assumed that high consumers would eat no more than an 
average of 19.8 grams of seafood per day. Kepone is a suspect carcino- 
gen pesticide that was manufactured at Ho]^ewell, Virginia, from 1966 
to 1975. The substance has contaminated fish and shellfish in the 
James River and parts of the Chesapeake Bay in Maryland and Vir- 
ginia. Since the Kepone-afiectcd area boasts a well established local 
seafood industry, it is likely that the actual per capita amount of 
seafood eaten by the highest seafood consumers in the area more closely 
approximates the Library of Congress estim.ate, which is more than 8 
times as high as the figure used by EPA. 

Finally, EPA's use of consumption statistics that are more than a 
decade old is~irr advised because eating habits are changing in the 
United States. The Library of Congress report states: 

Since 1965 we have seen some major shifts in food consumption in the U.S. 
Pork, egg, milk and cream, butter and lard, sugar, and wheat flour consumption 
has declined on a pounds per capita basis. And consumption of poultry, chicken, 
cheese, margarine, shortening and oils, fresh fruits, fresh and frozen vegetables, 
and corn syrup and sweeteners has increased.'*^ 

A new 1977-78 household consumption surve3% similar to the one 
conducted in the sixties, is underway at the USDA. How^ever, data 
from this survey will not be available for at least several months. 



^' I/ibrary of Congress rer.ort, "Cov^idernfjons in the Use of USDA Consumption Statistics in the Setting 
of PfS'icide Tolerances by the Environmental Protection Agency,'' p. 5. 
*2 See Ibid., p. f>. 
« Ibid., pp. fi and 7. 
" Ibid., p. 7. 



14 

3. EXEMPTIONS FROM THE TOLERANCE SETTING REQUIREMENT 

Under the law, EPA has the authority to exempt certain pesticides 
from the tolerance setting requirement. According to section 408 of 
the Federal Food, Drug, and Cosmetic Act: 

The Administrator shall promulgate regulations exempting an}^ pesticide chemi- 
cal from the necessity of a tolerance with respect to use in or on any or all raw 
agricultural commodities when such a tolerance is not necessary to protect the 
public health. *5 

Sections 180.1001-180.1035 of the Code of Federal Regulations list 

the pesticide ingredients that the Environmental Protection Agenc}" 

and the Food and Dru^ Administration (prior to 1970) have exempted 

from the tolerance requirement. The list of exempt substances includes : 

More than 1,000 ''inert" ingredients. (Chemicals classified as 

inert are not necessarily unreactive. Classification as ''inert" 

simply means that a substance does not have active pesticide 

properties.) "Inert" chemicals approved for use are automatically 

tolerance exempt.*^ 

Approximately 50 ingredients that are active pesticides. (Some 

are exempt for general agricultural use. Others are exempt only 

for specific uses.) '^^ 

The law states that an exemption is to be granted only when "a 

tolerance is not necessary to protect the public health." Part (a) of 

section 180.1001 of the Code of Federal Regulations, which introduces 

the list of exempt chemicals, states a clear internretation of the 

FFDCA: 

An exemption from a tolerance shall be granted when it appears that the total 
quantitj'^ of the pesticide chemical in or on all raw agricultural commodities for 
which it is useful under conditions of use currently prevailing or proposed will 
involve no hazard to the public health. ^^ 

During a public meeting of the Study Group on Pesticide Toler- 
ances of EPA's Science Advisory Board, held on June 27 and 28, 1978, 
Joseph Cummings, Chief of the Chemistry Branch of EPA's Regis- 
tration Division, Office of Pesticide Programs, stated his concern about 
some tolerance exemptions for both "active" and "inert" pesticide 
ingredients that are now known to pose health risks. Mr. Cummings 
cited Carbon Tetrachloride and Ethylene Dibromide as examples. 

Carbon Tetrachloride, an active pesticide which is exempt from the 
tolerance requirement when used as a fumigant^^ for barley, corn, 
oats, popcorn, rice, rye, sorghum, and wheat, is currently undergoing 
EPA's pre-RPAR review j)rocess. The substance has been shown to be 
oncogenic, mutagenic, teratogenic and potentially carcinogenic. ^° In 
addition it has shown embryotoxic^^ and hej)atoxic^- potential. 

Ethylene Dibromide, another active pesticide which is exempt 
for specific I'umigant uses, is currently undergoing the RPAR process. 
Ethylene Dibromide is a known mutagen and tumor inducer that has 
also caused reproductive i)i-oblems in bulls, mice, rats and chickens. 



*i Federal Food. DniR, and Cosmetic Act. as amended; 21 U.S.C. 3t(ia(e). [FFDCA sec. 498(b).] 
« Ood'^ of Federal Hefnilatioiis. see. ISO. 1001. 
*^ Code of Federal IteRiilalioiis. sees. 180.1002-180.1035. 
« Code of Federal ReKMalioiis, .«ec. 180,1001. 

" Funiigaiils arc vaporized i)esii(ides, usually applied post-harvest in confined spnccs to kill fungus or 
in. sect r>csts. 
»" See footnotes 10-12 for definitions. 
«' I'osse ;-iiie qualities toxic to the embryo. 
42 Possessing (lualities toxic to liver cells. 



15 

Chloroform, a suspect carciiioircn, whicli is also one of EPA's to|) 
priority RPAR siibstanres, is tolerance exemj)! for use as a fumitrant 
on certain grain crops. Chloroform has demonstrated oncogenic; power 
in rats and mice. It is also suspected of causing kidney and liver 
<lamage. 

All of the above highly hazardous substances were thought to pose 
no risk to the public health when they were exempted from the toler- 
ance requirement for use as fumigants. Although chemicals that have 
demonstrated pot-ential to cause serious health problems may pose 
no risk when they are used for the purposes for which they were 
exempted for, EPA cannot guarantee that the public is at no risk 
with respect to certain tolerance-exempt chemical agents. 

For example, resichies of the fumigant Ethylene Dibromide have 
been found in citrus fruit peel. While the government once thought 
that fumigants would not result in harmful residues in food, this 
theory has been proven false. 

In 1976, EPA commissioned Potomac Research, Inc. to identify 
all ''inert" (and therefore tolerance exempt) chemicals in pesticides 
that posed potential health or environmental hazards. The results of 
this investigation were printed on September 30, 1977, in a report 
entitled The Investigation and Classification of Inert Ingredients in 
Pesticide Formulations.^^ The introduction to the report states: 

In evaluating the safety of pesticides, toxicologists have required extensive 
long and short term toxicological testing of the active ingredients of the pesticide. 
Generally little or no toxicological information on other ingredients of the formula- 
tion, i.e., the inerts, has l)een required. The 1974 discovery that vinyl chloride, an 
inert propellant used in some pesticide aerosols, causes a rare form of liver cancer 
brought about the necessity- for thoroughl}- evaluating the potential danger of 
inert ingredients.^ 

Potomac Research investigators evaluated all inert pesticide in- 
gredients for their toxicological effects on health and the environment 
and classified them in six categories accordingly. Fifty-two chemicals 
were listed in classes "1" and "2", defined as follows: 

Class 1 — This category of inerts contains those found to have chemical, toxi- 
cological or environmental characteristics that require immediate attention. 

Class 2 — Available data indicate probable cause for alarm because chemical 
structure is similar to a known toxicant, or a metabolic environmental pathway 
may result in breakdown to known toxicant, or irreversible chronic eflects are 
known, e.g., neurotoxicity, irreversible eye damage, skin sensitization, etc. 
Massive fish kills or other environmental effects also triggers [sic] this category." ^5 

Among those 52 inert ingredients classified In Classes 1 and 2 was 
Dioxane (Class 1), used as a solvent and cosolvent in pesticides. 
According to Potomac Research, Dioxane also functions as a solvent 
in "resins, oils, waxes and some dyes, and as a solvent for electrical, 
agricultural and biomedical intermediates and for adhesives, sealants, 
cosmetics, pharmaceuticals, rubber chemicals and surface coatings."''^ 

Dioxane is a known carcinogen that, according to the report: 

produced malignant tvimors of the nasal cavity and liver in rats and tumors of 
the liver and gall bladder in guinea pigs. It was also active as a promoter in ati 
two-stage skin carcinogenesis study in mice." 



55 Potomac Research Inc., "The Invest! e;ati on and Classification of Inert Ingredients in Pesticide Formu- 
lations", EPA contract 68-01-3431, Sept. 30, 1977. 

« Ibid., p. 1. 

55 Ibid., p. 33. 

66 "Inert Ingredients of Pesticide Formulations", EPA contract 68-01-3131, EPA accession number and 
name: 000706 Dioxane (data and evaluations for particular inert ingredients accompany report mentioned 
above.) 

s' Ibid. 



16 



In addition: 



Human deaths from accidental poisoning through inhalation and skin absorp- 
tion of 1,4-dioxane have been reported. ^'^ 

One worker died as a result of a week's exposure to 500 parts ])er 
million of 1,4-dioxane. An autopsy revealed liver, kidne}^ and brain 
damage. Five other acute deaths due to Dioxane exposure have been 
attributed to hemorrhagic nephritis (kidney hemorrhage) and liver- 
necrosis.^^ 

Phenarsazine oxide is another tolerance exempt substance that was 
given a ''Class 1" rating in the Potomac Research report. This sub- 
stance is similar in structure and composition to Phenarsazine chloride, 
which is used as a war gas, j)roducing severe pain in the chest, nose 
and sinuses, coughing, vomiting, and sensory distrubances. Phenarsa- 
zine Oxitle is an arsenic compound. According to the report, ''The 
evidence is now overwhelming that arsenic is a carcinogen in man".^^ 

Clinical reports have documented an association of chronic arsenicism with 
skin cancer in vineyard workers. The risk of lung cancer is clearly increased in 
certain smelter workers who inhale high levels of inorganic arsenic compounds. ^i 

Triethylamine is another inert pesticide chemical listed as a po- 
tential health hazard in the report.^- Nitrosamines, which are powerful 
carcinogens, are produced when Trieth^damine reacts with nitrous 
acid. According to Potomac Research, Inc. : 

Under certain circumstances, triethylamine can react with nitrites to produce a 
highly potent carcinogen, the corresponding nitrosamine. An example using 
morpholine along with nitrites in the diet with a consequent high frequency of 
tumor production has been the subject of several publications. The controversial 
addition of nitrites to bacon and sausages is another example. Because of the 
inherently explosive publicity that could l^c generated by others, it would l)e 
highlv desiral)le for P]PA to have investigations underway to determine the cir- 
cumstances that could lead to nitrosamine production from triethjdamine.^^ 

Two additional major problems associated with tolerance exemp- 
tions were spelled out by Mr. Cummings and Dr. Reto Engler of the 
Toxicology Branch, OPP, at EPA's Jime Science Advisory Board 
meeting on pesticide tolerances : ^^ 

When an exempted pesticide ingredient is misused, it is very difficult for the 
EPA to take legal action. A tplerance-exempt pesticide ingredient is not legally 
violative at any level. While the FUA may recommend that EPA set an "action 
level" (a legal limit that is set when high r(>sidues of a chemical are found in 
situations where no appropriate tolerance exists), such a procedure is remedial 
at l)est rather than preventive and does not assure effective protection of the 
public health. 

Even more serious, however, is a prol)lem involving monitoring and detection. 
The FDA is required to monitor pesticides with tolerances for violative levels of 
residues in foods. When a petitioner applies for a tolerance, he or she is required to 
submit an effective method for detecting residues of the pesticide chemical and 



*8 Ibid 

«« 'I'hp subcommittep learnod during a foHovviip invesligalion (September 1978) that . while no "inert"' 
pesticide forniuiations have yd undergone the RPAR review process. 1. 1-dioxape is 1 of / inerls that have 
been accci.tf'd for "pre-RRAR" assessnient. However, as of Sept. 2o. 1978. 1, 4-dioxane still had not been 
assigned to any particular scienUst for consideration. Other inerts accepted for pre-RI AR re vievv- status 
are asbestos, ethylene diamine, tetraacetic acid, maleic anhydride. 2-lmida7.ohonethioiie (El U) tri- 
ethylamine, and triethyl phosi)hate. The latter three, like 1, 4-dioxane. have not yet been assigned to EPA 
personnel. As staled earlier in this report, the RPAR proce.^^s is proceedmp: slowly. 

60 Potomac Research, Inc., "Inert Ingredients of Pesticide Foriuulations EPA accession number and 
name: (KK)119 phenarsazine oxide. 

«| Ibid. 

«-' See footnote 59. . m t-.ti * • i i 

«3 Potomac Research, Inc., "Inert Ingredients of Pesticide Formulations , EPA accession number and 
name: (X)IOS.') triethylamine. 

w Meeting held at EPA headciuarters, June 27-28, 1978. 



17 

its metal)olites on the crop for which he or she is requesting the tolerance. But 
when the EPA exempts a pesticide from the tolerance requirement, the agency also 
exempts the petitioner from having to provide a detection method for residues. 
Therefore, the Food and Drug Administration is not supplied with a means for 
monitoring food for the exempt pesticide ingredient. 

Thus, when a potential health risk does develop involvini^ an exempt 
pesticide chemical, miless the problem reaches serious and immediately 
evident proportions, it is apt to go unnoticed by the federal govern- 
ment. Because cancer and other ill eil'ects may take many years to 
develoj), with no signs of danger present in the interim, unmonitored 
and potentially hazardous chemicals in our food may, be causmg as 
yet unrecognizable damaging health effects. 

(a) Other deviations from standard tolerance setting 

During its 1975 review of EPA's pesticide programs, the General 
Accounting Office found numerous examples of pesticides that were 
not officialh^ exempted from the tolerance requirement, but were 
nevertheless marketed without prior establishment of proper tolerances. 

GAO's 1974 report, Federal Pesticide Eegistration Program: Is it 
Protecting the Environment Adequately from Pesticide Hazards.^ illus- 
trated on a common tolerance setting deviation: 

EPA has established a S3'stem of interim tolerances to allow using a pesticide 
while the review of the tolerance petition is in progress. Interim tolerances were 
usually established when (1) questions of safet}' existed, (2) inadeciuate data was 
provided on residue levels, and (3) petitioners su))mitted no data to support the 
safety of the proposed uses. Such tolerances are not consistent with EPA's man- 
date to protect the public health. ^^ 

GAO based these findings on an overall study of the interim toler- 
ance SA^stem, with specific attention given to six individual cases. 
GAO's recommendations to EPA regarding interim tolerances, con- 
tained in the 1975 report, included the following: 

[EPA should] Reassess the need for and adequacy of data submissions for all 
interim tolerances; interim tolerances found unnecessary or lacking sufficient data 
should be canceled if the data is not submitted by a set deadline. ''« 

On September 11, 1975, EPA agreed to "accept" and ''implement" 
the recommendations contained in the GAO report. ^^ 

More than two years later, in November of 1977, this Subcommittee 
asked the Government Accounting Office to conduct a follow-u]) study 
to assess the adequac}^ of EPA's response to the 1975 recommendations. 

During the follow-up study, GAO reexamined the six individual 
cases that were singled out in the 1975 review. As of January 1978, one 
of the interim tolerances had expired, two were converted to ])er- 
manent tolerances, while three retained interim tolerance stattts. EPA 
told GAO that the three interim tolerances which remained in effect 
had not been canceled or converted to permanent status because 
data gaps still existed.^^ 

GAO Community and Economic Development Division Director, 
Henry Eschwege, explained another serious EPA deviation from the 
standard tolerance setting requirement to the Subcommittee on 
February 14: 

We [GAO] had reported that in June 1972 EPA's toxicology Ijranch strongly 
objected to the continued registration of chlordane, endrin, heptachlor, and 

65 GAO report, supra note 16, at p. 51. 

*s Ibid., p. 65. 

6' See Ibid., App. I, p. 83. 

68 Hearings, supra note 8, p. 7. 



18 

silvex for certain uses because available toxicity data did not support the proposed 
tolerances or because residue data was insufficient to determind appropriate 
tolerances. However, the Office of Pesticide Programs overruled the toxicology 
l)ranch, stating that absence of a tolerance did not preclude registration of the 
uses and that there seemed to be only a weak case for cancellation. 

As of January 1978, EPA had not set tolerances for any of the questioned uses 
of chlordane, endrin, heptachlor, and silvex — all of which are suspected of causing 
cancer and other tumors. The manufacture of chlordane and heptachlor was 
suspended on July 30, 1975, but as yet the registrations have not been canceled. 
Further, endrin is undergoing EPA scientific scrutiny to determine v.hether 
cancellation action is warranted and silvex is being considered for similar scrutiny. ^^ 

Deviations from the tolerance setting requirement of the FFDCA 
are allowing pesticides which ma}^ be health risks to remain on the 
market. While the law is written to exempt onh' innocuous substances 
from the tolerance setting requirement, EPA has a history of inter- 
]:)reting the statute to exempt some which ma}' pose major health 
risks. 

3. SUMMARY OF SUBCOMMITTEE FINDINGS AND CONCLUSIONS 
CONCERNING EPA TOLERANCE SETTING 

The Subcommittee concludes that EPA is not providing the Ameri- 
can public with adequate protection from the potentially harmful 
effects of man}^ pesticides. The safe use of pesticides is contingent 
upon a strong and effective tolerance setting program. Although evi- 
dence continues to accumulate that at least 25% of all marketed pesti- 
cides are potentially carcinogenic, EPA has not made use of its 
Congressional mandate to protect the public. 

Moreover, EPA has failed to commit the resources necessary to 
])roperly protect the public. Not one position out of the more than 
1,000 allotted jobs in EPA's pesticide programs is devoted specifically 
to tolerance reassessment. 

Additionally, the action that EPA has proposed to take with regard 
to the Science Advisory Board is wholeh^ inadequate and may serve to 
dela}^ the direct regulatory action which EPA must take. EPA should 
not use the deliberations of the Science Advisoiy Board as an excuse 
for inaction. 

More specifically, the Subcommittee finds that: 

1. One-sixth of established tolerances are for pesticide ingredi- 
ents that may be classified as suspect carcinogens. Man}' scientists 
now believe that even low levels of suspect carcinogens cannot be 
consumed safel}'. Yet, EPA continues to employ a system for 
tolerance setting which ignores this potential danger and to estab- 
lish tolerances for suspect carcinogens. 

2. EPA files are replete with safety test data gaps. EPA ad- 
mitted in 1975 that at least 442 registered pesticides lac'ked 
important safety data. Studies indicate that many pesticides 
which result in chemical residues in food and animal feed have 
never been tested for their j)otential to cause cancer, birth defects, 
and genetic mutations. Because test data for teratogenicity was 
not required until 1063 and data for mutagenicity was not re- 
quired until 1970, most pesticides registered before those dates 
lack proper safct}' test data. Additionally most of these pesticides 
have not been reassessed. EPA has not taken sufficient action to 
correct this situation. 



" Ibid, pp. 6-7. 






fl9 

3. Some pesticide ingredients that are now known to pose potential 
health problems have been exempted or j)artially exempted from 
the formal tolerance requirement. While the Federal Food, Drup: 
and Cosmetical Act allows exemption for chemicals that are 
judged safe when used for certain purposes, recent findings have 
linked the use of some previously exempt chemicals to increased 
health risks. Moreover, EPA has a j)ractice of granting "interim 
tolerances" for some pesticides absent safety test data. Interim 
tolerances exist today for some chemical j)esticides that have 
have never been proven safe. The Subcommittee finds this prac- 
tice ill-advised and contrary to the statutory mandate. 

4. The average per capita daily consumption statistics which 
EPA uses as its ''Food Factor" in establishing tolerances are in- 
accurate and outdated. These figures which allegedl}'' reflect 
average consumption for specific food stuffs for the entire U.S. 
population are based on studies conducted by the U.S. Depart- 
ment of Agriculture over ten years ago and do not reflect signifi- 
cant changes in the eating patterns of Americans which have 
taken place over this period. Additionally, the Subcommittee 
found numerous examples of tolerance levels which are based on 
grossly underestimated consumption levels. Tolerances based on 
these statistics do not provide consumers with proper protection 
from potentially unsafe pesticide residues. 

5. Pesticide tolerance levels are often higher or lower than the 
actual amount of residue which may be found in or on commodities 
on which the chemicals have been aj)plied. Those tolerances that 
are not based on accurate residue data are not useful either for 
assuring public protection for or legal enforcement of proper 
pesticide use. 

6. In 1975, EPA agreed to ''accept" and "implement" Govern- 
ment Accounting Office (GAO) recommendations designed to 
rectify program inadequacies and to improve the tolerance 
setting system. However, as of February 1978, GAO was forced 
to conclude that EPA had made "little tangible progress" to- 
ward implementing GAO recommendations and thereby had 
faikd to significantly improve its tolerance setting program. 

r 7. The Federal Food, Drug, and Cosmetic Act protects the 
/ public from j)otential cancer-causing chemical food additives. 
/ However, the Federal Food, Drug and Cosmetic Act (FFDCA) 
/ does not apply to the tolerance setting program. EPA sets tol- 
/ erances based upon the less ])rotective legislative language of the 
I Federal Insecticide, Fungicide, and Rodenticide Act (FIFFKA). 
The Subconunittee finds that this process lessens public pro- 
tection. 

8. Required safet}^ tests for pesticides (tests for cancer, bii-th 
defects, etc.) are often conducted by or for parties which have a 
vested interest in marketing the pesticide and not by an objec- 
tive scientific group ^^•ith no commercial interest in the sale of the 
product. There is no federal compliance testing ])rogram to evalu- 
ate these data. As a result, EPA is forced to set many tolerances 
on unverified test data which ma^^ not full}' assess the j^otential 
dangers of the pesticide in question. 



20 

4. SUBCOMMITTEE RECOMMEXDATIOXS COXCERXIXG EPA TOLERAXCE 

SETTIXG PROGRAM 

A. The Subcommittee recommends that Congress: 

1. Consider enacting legislation making it unlawful to use 
potentially carcinogenic, mutagenic and teratogenic pesticides 
on raw agricultural products, unless it can be established that no 
residues of these products or potentially harmful metabolites 
from these products remain on the food. 

2. Provide additional funds to EPA for safety reevaluation of 
pesticides. This program should provide priority review for 
pesticide products which may pose significant health risks to the 
public. 

3. Consider legislation to place the tolerance setting respon- 
sibilities of EPA under the authority of another Federal agency 
more sensitive to public safetA' in the event that EPA continues 
to maladminister the program. 

B. The Subcommittee recommends that EPA: 

1. Cancel tolerances for pesticides which result in potentially 
carcinogenic, mutagenic, and teratogenic residues in or on raw 
food stuffs. EPA should establish a program and specific time- 
table to accomplish this as soon as possible. 

2. Recpiire from manufacturers all safet}" test and residue data 
be supplied within a specific period of time. 

3. Begin an immediate and intensive reassessment of all tol- 
erances through its Office of Pesticide Programs. Positions devoted 
solely to tolerance reassessment should be created and filled. 

4. Reassess all tolerance exemptions. Substances that were 
granted exemptions from, the tolerance requirement before car- 
cinogenicity and other ill effects were linked to pesticides, should 
have their tolerances revoked if evidence shows that such sub- 
stances are potentially hazardous. 

5. Discontinue the practice of exempting all ''inert" pesticide 
ingredients from the tolerance requirement. EPA should develop 
a system for proving ''inert" pesticide ingredients safe ])rior to 
approving them for use. Such a system should go into effect no 
later than January of 1980. 

6. Closely scrutinize all residue data for existing tolerances as 
part of its tolerance reassessment. Tolerances which do not corre- 
spond to updated and accurate measurements of residues left 
on crops following pro|)er pesticide application should be read- 
justed. If it is necessary to raise tolerance levels to supi)ort data 
indicating the actual amounts of residues found on crops, new 
safety tests should be required which reflect the increase in the 
level of residue ])resent. An increase in the tolerance sliould not 
be approved unless it can be i)roven that the new level will not 
adversely affect public health. 

7. (liange its method of computing the "Food Factor." The 
highest per capita daily consumption groups, based on age, sex 
and geogTai)hic information rather than national averages, should 
be considered in establishing Food Factors. All infant foods, in- 
cluding milk, should be given special consideration. If the EPA 
is to continue to use data gathered by the U.S. Depai tment of 
Agriculture, that data should be tailored specifically to identifi- 
cation of highest risk consumers for specific foods. 



21 

8. Develop a workable monitorin^j: system for safety tests con- 
ducted by industry. One solution could be to establish a system 
of Lrovernment-approved independent ])rivate laboratories. EPA 
should develop standards for such laboratories utilizing objective 
scientific testinir criteria. 

9. Abandon immediately the practice of issuin^i' ''interim tol- 
erances." A pesticide that has not been proven safe or is suspected 
of posinc: a health risk does not belong- on the market. Interim 
tolerances should be revoked for pesticides that lack test data. 

10. Cancel tolerances for pesticides which do not degrade within 
a specified period of time and tolerances for those which degrade 
into dangerous metabolites. Since tomorrow's scientists may prove 
today's chemicals unsafe, only readily and safely degradable pes- 
ticide ingredients should be ap})roved for use in the future. EPA 
should develop a firm policy concerning pesticide decomposition 
time and apply it to the tolerance setting program. 



Chapter III 

United States Department of Agriculture (USDA) : Chemical 
Residue Monitoring of Meat and Poultry 

1. background 

The United States Department of Ao:riculture (USDA) shares re- 
sponsibihty, with the Environmental Protection Agency (EPA) and 
the Food and Drug Administration (FDA), for protecting the Ameri- 
can pubhc against harmful chemical residues in food. USDA, which is 
responsible for ensuring that meat and poultry are kept off the market 
when they contain unsafe levels of chemical resichies, conducts two 
residue monitoring programs: the ''random sample" program and the 
^'pretest", ''hold and test" or "surveillance" program. 

Under the random sample monitoring ])rogram, USDA inspectors 
collect tissue samples from a percentage of randomly selected animals 
in slaughterhouses. USDA then analyzes these samples for residues of 
pesticides, animal drugs, and environmental contaminants. If a 
sample exceeds an established tolerence (maximum amount of a 
chemical that may be legally present in a particular commodity), 
USDA reports the violation to the FDA for investigation and possible 
prosecution. Cases of suspected pesticide misuse are reported to EPA 
as well. Pesticide tolerances for meat and poultry are established by 
the EPA and tolerances for drugs administered to animals are set 
by FDA. 

Under the "pretest", "hold and test" or "surveillance" program, 
USDA orders a grower to submit samples from his or her herd for 
laboratory analysis when (1) outward signs of chemical contamina- 
tion are evident in animals, (2) a grower has shi])ped animals with 
illegal residues to slaughter in the past, or (3) the USDA is conducting 
a special survey. 

This chapter will evaluate the United States Department of Agri- 
culture's monitoring programs for chemical residues in meat and 
poultry. The Subcommittee's findings, conclusions and recommenda- 
tions will be presented at the close of the chapter. 

2. usda's monitoring programs for chemical residues in meat 

and poultry 

On February 24, 1978, Carol Tucker Foreman, Assistant Secretary 
for Food and Consumer Services of the United States Department of 
Agriculture, offered testimony before the Subcommittee concerning 
USDA^s monitoring programs for chemical residues in meat and 
poultry. Ms. Foreman explained USDA's jurisdiction to the Sub- 
committee: 

Under the terms of the Meat and Poultry Inspection Act, meat and poultry- 
products are adulterated, and, therefore, are prohibited for use as human food 
if they contain more than permitted quantities of literally scores of chemical 
substances. 

(23) 



24 

These chemical substances include pesticides, trace elements, drugs, feed addi- 
tives, and industrial chemicals which may be harmful to human health. 

Our job at USD A is to devise means to make sure harmful residues of these 
chemicals are not present in meat and poultry products. 7" 

However, Ms. Foreman acknowledged, ''We have not been as 
successful in controlling these residue problems as we should be," ^^ 
and she admitted later in her testimony, ''There are serious vreaknesses 
in our program." '^ 

At least 143 pesticides and drugs are known to leave chemical 
residues in meat and poultry. Pesticides remaining as residues in 
animal feed crops may be ingested by livestock and stored in their 
tissues. Pesticides can result in resichies in meat both when they are 
applied directly on feed crops and when they are present as general 
environmental contaminants. 

Animal drugs are used b}^ growers nationwide. Drugs administered 
to livestock, which include antibiotics and sulfas, are often misused by 
growers, leaving illegal residues in animal tissues and subsequently 
in meat. 

Forty of the animal drugs and pesticides known to occur as residues 
in meat and poultry are suspect carcinogens. Eighteen are suspected 
of causing birth defects. Yet only 46 of the 143 drugs and pesticides 
occurring in edible animal tissues are monitored by the USDA. The 
following table lists the animal drugs and pesticides suspected of 
causing cancer and birth defects, which remain as residues in food- 
producing animals but are not monitored in meat and poultry by the 
federal government : 

Suspect Carcinogens Not Monitored in Meat and Poultry by 

USDA 

Animal Drugs. — Chlomadinone Acetate Dim.etridazole; Estradiol 
Benzoate, Estradiol Monopalmitate, Furazolidone, Gentian Violet 
(not approved for use as an animal drug, but reported used), Alelen- 
gestrol Acetate, Progesterone, Testosterone. 

Pesticides. — Captan, Carbaryl, Chlorobenzilate, Dimethoate, 
Maneb, Perthane, Piperonulbutoxide, Polyram, Silvex, 2,4-5-T, TDE, 
Zincion and Maneb Coordination Product, Zineb. 



Suspect Teratogens (Causers of Birth Defects) not Monitored 
in Meat and Poultry by USDA 

Animal Drugs. — Chlormadinone Acetate, Reserpine. 

Pesticides. — Captan, Carbaiyl, 2,4-D, Demeton, Diphenl^^amine, 
Fenthion, Maneb, Paraquat, Pentachlorophenol (photodegrades to 
dioxiii). Silver (based on dioxin contaminant), 2,4,5-T (based on 
dioxin contaminant), Zineb, Benomyl.^^ 

Some chemicals which occur as resi(kies in meat and poultry are not 
monitored because USDA has no means to test produce for their 

70 Hearings, supra noto 8, p. 209. 

71 Ibid. p. 2(K». 

72 Ibid. p. 212. 

73 Information supplied to the subconimiltee by the Concral Account iiig Ofl'ice. Hearings, svpra note 8, 



25 

presence. Oilier substances i2:o largely unmonitored because ''multi- 
residue" detection methods (tests for several chemicals simultaneousl \) 
do not exist for them and USD A prcl'ers to use only tests that look lor 
many substances at a time. 

Ms. Foreman told the Subcommittee that another reason USDA 
does not monitor many chemicals in meat and poultry is lack of 
resources and })ersonnel. Less than 1 percent of USDA's total meat 
and poultry ins})ection budget of $255,017,000 (FY 78) is devoted to 
chemical monitoring of meat and j)oultry. 

Equally as serious as the Agriculture Department's failure to lest 
for many chemicals known to occur in meat and poultry, is the follow- 
ing USDA j^rogram weakness, described to the Subcommittee l)y 
Gregorv J. Ahart, Director of the Human Resources Division, General 
Accounting Office (GAO), on February 16, 1978: 

With few exceptions, neither the Department [USDA] nor FDA can locate and 
remove from the market raw meat and poultry found to contain illegal residues. 
Most was sold to the pul)lic.7* 

Mr. Ahart went on to explain to tlie Subcommittee the major 
reasons why most meat containing illegal levels of chemical substances 
is not removed from the market: 

"the Department cannot [legally] detain raw meat and poultry pending results 
of sample analysis unless it has reason to believe the animal is violative. 

Meat and poultry aie generally marketed within 48 hours after slaughter, and 
sample analysis usually takes between (> to 25 daj^s to complete. 

Finally, meat from violative animals cannot be identified once the animal 
has been slaughtered." ^^ 

By the time the United States Department of ilgriculture has 
discovered a pesticide or animal drug tolerance violation in its random 
sample monitoring program, the contaminated carcass has already 
been divided into cuts, shipped to retail stores and sold to unsuspecting 
customers. Only in rare cases, for instance where a frozen seasonal 
product such as turke}^ is concerned, is recovery of contaminated 
meat or poultry possible. And because meat is not tagged from farm 
to market, it is often difficult to track down growers suspected of 
shipping violative animals to market with nothing but USDA 
slaughterhouse samples as leads. 

jA. USDA^s random sample monitoring program. 

Every carcass receiving the USDA inspection stamp is examined 
for cleanliness and outward signs of health. However, only 1 in 8,000 
livestock and 1 in 700,000 poultry are tested in USDA laboratories 
for chemical residue content, facts which led Chairman Moss to 
remark during the February 16th hearing: 

A housewife who carefully checks the meat and poultry she buys to determine 
that it has a USDA-inspected stamp on it is merely getting a product that has 
been inspected for . . . cleanliness and general health— but in no way does that 
imply that there has been an inspection to determine whether or not it is an 
adulterated product because of high residues of the products we've been talking 
about.76 



74 Hearing, supra note 8, p. 99. 

75 Ibid. 

7« Ibid, p. 204. 



26 

Between the years 1974 and 1976, USDA random sample testing 
for animal drugs, pesticides and general environmental contaminants 
such as mercury and lead, yielded the following violation rates: 

Percent 

Cattle 14. 96 

Calves 8. 84 

Swine 15. 83 

Chickens 5. 08 

Turkey 773, 4(3 

With rare exception, most violative (containing illegal levels of 
chemical residues) meat products were sold to the public. Using a 
straight line projection of the amount of meat sampled for various 
chemical residues versus the total slaughtered and the number found 
violative, an estimated 1.9 million tons of beef and 1.1 million tons 
of swine containing illegal levels of chemical residues were sold to the 
public in 1976. Most of this meat bore the USDA inspection stamp. 

Ahart suggested measures that would improve the present USDA 
Random Sample monitoring program during hearings on February 16: 

If you're going to have the capability to remove, or keep, raw meat and poultry 
from the market, you have to go one of two waj^s. You either have to have a sys- 
tem under which you can identify the products through the whole marketing 
process — the tagging system as we call it here — or you must have the capa- 
bility — to test the meat and poultry at the slaughterhouse within a 24-hour 
period before it gets in the marketing distribution chain. ^^ 

Assistant Secretary Foreman also testified to the need for both 
rapid residue test procedures and some sort' of animal identification 
system to increase the effectiveness of USDA's Random Sample 
monitoring program. 

/ B. Food and Drug Administration follow-up 

Violations uncovered by USDA residue monitors are reported to 
the Food and Drug Administration for investigation. FDA has the 
power to mete out criminal penalties to growers who ship violative 
animals to market. The bureau also has the authority to recall con- 
taminated meat and poultry. However, the Food and Drug Admin- 
istration only investigated 37 percent of 3,100 residue violation 
cases USDA reported to FDA between 1973 and 1976. From 1975 
to 1977 FDA prosecuted no residue violators and recalled no meat or 
poultry. 

Because FDA has the power to hand out criminal, but not civil, 
penalties, the bureau rarely prosecutes a grower unless he or she is a 
chronic violator. USDA's Random Sample monitoring program in- 
frequently identifies chronic violators. 

C. Animal drugs 

''The very productivity of American agriculture is based upon the 
use of chemicals to combat plant and animal diseases","® Assistant 
Secretary Foreman told the Subcommittee on February 24. 

"Unfortunately", she said, "we have devised animal husbandry 
practices, such as close confinement rearing, which cannot be used 
without (h'usrs to control disease." ^° 



" Information supplied to the subcommittee by the General Accounting Offlce. 
7« Hearings, supra note 8, p. 118. 
" Ibid, p. 208. 
w Ibid, p. 209. 



27 

Growers routinely administer drugs to their livestock. Sulfa drugs 
and antibiotics are commonly used to combat or prevent diseases 
which spread rapidly in" the cram])ed confines of modern feedlots. 
Drugs are also given to animals to quicken growth. 

According to Ms. Foreman, drugs administered to livestock are 
resulting in a high ])ercentage of illegal residues in meat. Ms. Foreman 
testified that USDA is experiencing a "major problem with antibiotic 
residues in dairy cattle and calves": 

We find 10 to 15 percent of the dairy cattle and 4 percent of the calves we test 
with violative levels of residues. 

The causes for this are not completely clear, but is appears to be primarily a 
situation where farmers are treating sick animals with antibiotics. When the 
animals fail to respond, some farmers ma}' send them to slaughter without first 
observing FDA drug withdrawal requirements.**^ 

Ms. Foreman also reported that 10 to 15% of the swine tested by 
USDA contain above-tolerance levels of sulfa drugs in their tissues. 
Sulfa drugs are added to swine feed to combat a disease called atrophic 
rhinitis and to increase growth rates. 

While the effects on humans who ingest meat contaminated with 
sulfa drugs and antibiotics are largely unknown, some scientists theo- 
rize that residues of these substances in meat could work to lessen the 
effectiveness of sulfas and antibiotics prescribed for human illnesses. 
At least two sulfa drugs prescribed for animals, Sulfamethazine and 
Sulfathiazole, have been hnked to cancer. ^- 

Of the sixty-seven animal drugs kno\\Ti to leave residues in meat and 
poultry, only twenty-six are included in USDA's chemical monitoring 
program and just three have detection methods that meet FDA cri- 
teria for follow up investigation and prosecution. 

Fifteen animal drugs are suspect carcinogens. Only six of these are 
part of USDA's official monitoring program and Arsenic is the only 
potentially carcinogenic drug that has a detection method sufficient 
for FDA follow-up purposes. The following table lists suspected car- 
cinogenic animal cirugs that were monitored in meat by the USDA be- 
tween 1974 and 1976 with corresponding numbers of samples that were 
found violative: 



Substance 


Number 
tested 


Number 

found 

violative 


Arsenic. 


6,986 


69 


Carbadox 


2,148 


13 


Diethylstilbestrol 


7,502 


47 


Ipronidazole . 


820 


17 


Sulfas 


8,016 


«300 









A violative sample is one that contains chemical residues at a level 
higher than the legal tolerance established by the FDA. However, 
many scientists now believe that no level of a carcinogen may be 
safely ingested by humans. ^^ Thus, even samples containing residues of 

SI Ibid, p. 211 

S3 The Subcommittee held hearings on the potential health threat posed by the misuse of antibiotics 
in animal feed on September 19 and 23, 1977. The infomiation obtained by this Subcommittee is contained 
in "Antibiotics in Animal Feeds" hearings before the Subcommittee on Oversight and Investigations of 
the Committee on Interstate and Foreign Commerce, U.S. House of Representatives, 95th Cong., 2d Sess., 
Ser. No. 95-68. 

^ Information supplied to the subcommittee by the General Accountinjr OfRce. 

^ See ch, 2, sec. 2, "The Tolerance-Setting Process and Carcinogenic Pesticides." 

34-433—78 3 



28 

potentially carcinogenic animal drugs within legal limits may be of 
some risk to consumers. 

Misuse of an animal drug is not a violation of the Federal Food, 
Drug, and Cosmetic Act. Regulator}^ action can only be initiated by 
the Food and Drug Administration when USDA and FDA can prove 
the marketing of violative meat. Gragory Ahart of the GAO told 
the Subcommittee on February 16: 

If misuse of an animal drug were a violation of the FD&C Act [Federal Food, 
Drug, and Cosmetic Act], FDA could establish a monitoring program designed to- 
identif}^ and correct conditions which could cause residue violations. ^^ 

Under the current system, violative growers are rarely identified 
and the combined efforts of FDA and USDA, therefore, do not effec- 
tively regulate the occurrence of toxic levels of animal drugs in meat. 

D. USDA pretest program 

When USDA has reason to believe that a grower has either shipped 
violative animals to slaughter in the past, or is present!}^ raising ani- 
mals that contain above-legal levels of pesticides or animal drugs, the 
Department can order the grower to submit to USDA's ''pretest" or 
''hold and test" residue monitoring program. Under the pretest pro- 
gram, USDA enjoins a grower to provide the DejDartment with labora- 
tory tissue analyses from samples of his or her herd before the suspect 
animals are sent to the slaughterhouse. A strong program to keep 
violative animals from reaching the slaughterhouse is essential since, 
once slaughtered, violative carcasses can rarely be identified in time 
to stop them from reaching the marketplace. 

However, during Subcommittee hearings, Gregory Ahart of the 
General Accounting Office, characterized USDA's pretest program as, 
"quite ineffective." ^^ Ms. Foreman expressed a concurring opinion 
based on the following facts which she related to the Subcommittee: 

Some livestock producers have learned to avoid hold and test restrictions by- 
selling their animals in distant markets or by marketing through middlemen. 

Since we [USDA] have no authority to quarantine and there is no national 
animal identification system, there is little we can do to prevent this.^^ 

According to Mr. Ahart, a GAO review of three USDA regional 
offices yielded that "pretest had not been completed by about 800 
[nearly two thirds] of the approximately 1300 growers required to 
submit animals for pretest between January 1973 and November 
1976." ^^ Because it is so easy tor growers to avoid the pretest require- 
ment by selling their animals in distant markets or to middlemen, the 
pretest program is no more effective than USDA's random sample 
monitoring program in protecting the public from chemically con- 
taminated meat and poultry. The USDA has no legal authority to 
quarantine suspect animals. Therefore, most growers simply circum- 
vent USDA's orders to submit to the pretest program. 

Ms. Foreman told the Subcommittee, "There is no question that 
we need some sort of quarantine legislation." ^^ She explained that a 
l)ro|)osal for such legislation was in the process of being drafted at 
USDA: 

8* Hearings supra note 8, p. 11&-117. 

87 find. p. 212. 
»3 Ihid..]). 100. 
t^Ibid. p. 213. 



29 

The kind of authoritj^ that we [at USDA] are considoring is authority to quaran- 
tine herds, flocks, and premises when a residue prohlem has been identified and 
the authority to require ownership identification of all livestock. ^o 

USDA believes that such authority would help the Department to 
administer its monitoring programs for chemical residues in meat 
more effectively. 

3. SUBCOMMITTEE FINDINGS AND CONCLUSIONS 

A. USDA's "random sample" monitoring program for chemical residues 
in meat and poultry is seriously inadequate. 

(1) A distressingly large number of pesticides and animal drugs 
known to leave residues in meat and poultry are not monitored by the 
USDA or any other federal agency. Many pesticides and animal 
drugs occurring in meat, both monitored and unmonitored, are 
suspected to cause cancer and/or birth defects. 

(2) USDA's tests for chemical residues in food take so long to per- 
form that by the time violative levels of chemicals have been detected, 
most contaminated meat has already been shipped to market and sold. 

(3) The USDA meat and poultiy inspection stamp is no guarantee 
that animal products are not chemically contaminated. The presence ol 
the USDA stamp means only that the food-producing animal was in- 
spected for visible signs of health. Most chemically contaminated meat 
goes to market bearing the USDA inspection stamp. 

(4) Less than 1 percent of USDA's total inspection budget is 
allocated for chemical residue monitoring of meat and poultry, a 
disproportionately^ small amount in relation to the seriousness of the 
health risks posed by ingestion of chemically contaminated food. 

B. USDA's "pretest" monitoring program, under which known vio- 
lators are ordered to submit laboratory samples from their herds to the 
Department Jails to keep contaminated meat of the market. The USDA 
has no authority to quarantine animals that it suspects contain viola- 
tive levels of chemical residues. Consequently, growers who have been 
ordered to submit to USDA's pretest program may circumvent the 
orders by selling their animals in distant markets or to middlemen. 
No government regulation requires a uniform identification system 
for livestock sent to slaughter. 

C. Drugs administered to livestock are often misused^ resulting in 
dangerous residues in meat. According to the USDA, the modern 
practice of ''close confinement rearing" depends on the use of drugs 
such as sulfas and antibiotics to control disease. While such an agricul- 
tural system may be economically expedient, it could be creating a 
national health risk. 

4. SUBCOMMITTEE RECOMMENDATIONS 

A. The Congress should consider legislation, giving the United 
States Department of Agriculture the authority to detain animals 
suspected of contaming violative residues of chemicals pending the 
results of laboratory tests. 

B. A national identification system for food-producing animals 
fihould be developed so that growers will not be able to avoid sub- 
mitting animals to USDA's "pretest" program. 

» Ibid. p. 213. 



30 

C. USDA should develop and utilize test procedures that can be 
completed within 48 hours in the slaughterhouse for all drugs, pesti- 
cides and environmental contaminants that are kno^\Ti to leave resi- 
dues in meat and poultry. Where multiresidue methods do not exist, 
USDA should consider using any available means to test for the 
existence of potentially hazardous contaminants in meat and poultry. 
No hazardous chemical residues likely to occur in meat should go 
completely unmonitored. 

D. USDA should allocate additional personnel and resources for its 
residue monitoring programs. The current 1 percent of the Depart- 
ment's total inspection budget which is allocated for residue monitor- 
ing is inadequate and should be increased no later than FY 1980. 

E. USDA's ''random sample" monitoring program should test more 
animals for chemical residues. Testing only 1 in 8,000 livestock and 
1 in 700,000 poultry does not afford a true picture of the extent and 
nature of chemical contaminants in meat and poultry. 



Chapter IV. — Food and Drug Administration (FDA) : Chemical 
Residue Monitoring of Foods Other Than Meat and Poultry 

1. background 

The Food and Drug Administration (FDA) plays three major roles 
in the federal effort to regulate pesticide and other chemical residues 
in food. The FDA: 

A_Ajj>Tiit'^rs lev^lg <^f pAst.ipulAft-iia foods other than meats and 
poultry to determine whether or not chemical residues exceed 
"leo-al tolerances established by the Environmental Protection 
Agency (EPA); 

B. Establishes tolerances for drugs administered to livestock 
which may leave residues in edible tissues ; 

C. Has the authority to prosecute when illegal amounts of 
pesticides and other chemicals are found during FDA's owTi 
monitoring program or during the United States Department of 
Agriculture's (USD A) surveillance of chemical residues in meat 
and poultry. Jurisdiction includes the authority to remove 
products containing illegal, or '^adulterative", residues from 
interstate commerce. 

This chapter will explore FDA's current roles in the federal pro- 
grams that are aimed at protecting the public from chemically con- 
taminated food. 

2. FOOD AND DRUG ADMINISTRATION SURVEILLANCE SYSTEM FOR 
chemical RESIDUES IN FOODS OTHER THAN MEAT AND POULTRY 

Donald Kennedy, Commissioner of the Food and Drug Adminis- 
tration, testified before the Subcommittee on February 24, 1978, about 
FDA's roles in the federal effort to regulate toxic substances in edible 
commodities. Dr. Kennedy described his conception of an ideal moni- 
toring system for chemical residues in food in his opening statement to 
the Subcommittee: 

As we [at FDA] see it, any residue surveillance system contains seven elements: 

1. A statistically valid program of food sampling that tracks usage and 
prevalence. 

2. An analytical ability to detect residues accurately and rapidly. 

3. An ability to follow up and remove violative products. 

4. The ability to amend or revoke tolerances without cumbersome adminis- 
trative procedures. 

5. A set of regulatory sanctions that deter repeated violations. 

6. An intelligence system that provides earl}^ warnings about potential prob- 
lems or changes in use patterns, production practices, or consumption habits, and 
criminal prosecutions, and is thus unable to successfully deter repeated violations. 

7. Adequate toxicological data on each chemical before it is approved, including 
an adequate analytical method." ^i 



»i Hearings, supra note 8, p. 256. 

(31) 



32 



T)r. Kennedy then added: 



As you will see from the account that follows, in a number of respects, the system 
'that the Food and Drug Administration has in place is not adequate." «2 

During its investigation and hearings, the Subcommittee found that 
Food and Drug Administration programs and procedures seriously 
lacking in all seven areas FDA Commissioner Kennedy cited as essen- 
tial elements of a chemical residue monitoring system. Specificially : 

1. No "valid program of food sampling that tracks usage and prevalence" 
exists. FDA's so-called "market basket survey", which analyzes a "typical total 
diet" for chemical residues, is not statistically valid and is not based on knowledge 
of pesticide and animal drug usage. 

2. Many toxic substances known to occur in food lack adequate detection 
methods and are therefore not monitored by the FDA. 

3. FDA infrequently removes violative products from the market. 

4. Tolerances are very rarely revoked. 

5. FDA has no authority to mete out civil penalties to those responsible for 
violations of chemical residue tolerances in meat and poultry, is reluctant to 
initiate. 

6. No central source keeps track of changes in toxic chemical usage, agricultural 
practices, consumption habits, etc. 

7. Tolerances have been granted (by EPA and FDA) for many chemicals ihat 
lack adequate toxicological data. 

A. FDA Residue Monitoring Program 

The Food and Drug Administration is responsible for monitoring 
Taw agricultural commodities other than meat and poultry for residues 
-of pesticides that have been approved for use by the Environmental 
Protection Agency (from 1970 to the present) or by FDA itself (prior 
to 1970). FDA's monitoring program is aimed at determining whether 
chemical residues remaining on mature produce are within the legal 
limits (tolerances) established by either EPA or FDA. 

FDA also monitors ''action levels", legal limits for chemicals which 
•cannot be lawfully used on food or animal feed crops, but are present 
in the environment and therefore show up as residues in food. Action 
levels are usually established by the EPA at FDA's request when high 
levels of non-tolerance chemicals appear in food. 

In its 1975 review of FDA's monitoring program for chemical 
residues in food the General Accounting Office turned up serious 
inadequacies in the scope of FDA's chemical monitoring. GAO recom- 
mended that FDA expand its surveillance program to include pesti- 
cide residues which were not being monitored. However, on Febru- 
ary 14, 1978, Henry Eschwege, Director of the Community and Eco- 
nomic Developm.ent Division of the GAO, told the Subcommittee that 
its 1977 follow-up review, performed at the Subcommittee's request, 
showed that: 

FDA did not concur with our [GAO's] recommendation to expand its surveil- 
lance program because FDA believed that over a period of years the results of its 
existing program had indicated that pesticide levels found in most agricultural 
commodities are generally well below established tolerances — violative levels of 
pesticides were found in only about 3 percent of the samples testcd.^^ 

However, Mr. Eschwege reported that GAO had reached a conflict- 
ing: conclusion: 



M Ibid. 

»? Ibid., p. 8. 



33 

We [at GAO] concluded that the 3 percent rate of violative samples FDA noted 
indicated that illegal residues do occur despite efforts to the contrary. This occur- 
rence demonstrated to us a need for FDA to initiate a systematic procedure to 
insure that all pesticides with tolerances are tested in FDA's surveillance program 
over a number of years.^* 

268 pesticides had legal tolerances for residues in raw agricultural 
commodities at the time of Subcommittee hearings. However, Mr. 
Eschwege told the Subcommittee that FDA's most commonly used 
''multi-residue" test only detects 73 chemicals. According to Mr. 
Eschwege, ''FDA has five additional multi-residue methods which 
would enable FDA to detect 34 additional pesticides, or a total of 
107 of the 268 ])estici(les. However, FDA was unable to ])rovide [GAO 
with] data on how many times the additional multi-residue methods 
were used." ^^ 

5,984 tolerances exist for the 271 pesticides now registered for 
agricultural use.^® (A separate tolerance is established for each crop 
on which a particular chemical is used.) 940 of the 5,984 tolerances 
are for chemicals which are suspected of causing cancer or other tumors. 
661 (70 percent) of these tolerances are for suspect carcinogenic pesti- 
cides not detected by FDA's most commonly used multi-residue 
method. 

Detection methods exist for many pesticides which remain as 
residues on crops, but are not routinely monitored by the FDA. Mr. 
Eschwege told the Subcommittee: 

Methodologies do exist for detecting residues of pesticides having tolerances. 
However, most of these methods are single residue methods that detect only one 
pesticide per analysis, Pal)lic exposure to the many pesticides detectable only by 
single residue methods is largely unknown because FDA has rarely used these 
methods. 87 

Therefore, toxic pesticides, including many that are suspect carcino- 
gens, are applied to the food we eat, but the federal regulatory agency 
with the duty to protect the public from such chemicals by preventing 
adulterated foods from entering commerce, the FDA, not only fails 
to prevent exposure, but does not even monitor for most toxic pesti- 
cide residues. 

When FDA uncovers a residue violation, it has the authority to 
remove affected produce from the market. Unfortunately, violations 
are rarely found in time for FDA seizure and most contaminated 
produce is sold to the public. During hearings on February 24, 1978, 
Commissioner Kennedy told the Subcommittee: 

By the time we have completed our analj^sis of a product and found an illegal 
residue, it is often very difficult for us to do more because the product has already 
been distributed in the marketplace.'*^ 

However, Commissioner Kennedy told the Subcommittee, "The 
picture isn't entirely bleak," pointing out that: 

Most state health or agricultural departments have administrative detention 
authority which enables them to hold products. We can, by working with state 
officials, sometimes prevent distribution of suspect products until the analytical 
work is completed.99 



95 7d. 

«« As of September 1978. 
w Ibid., p. 8. 
«8 Ibid., p. 258. 



34 

Expanding on the issue of state involvement in chemical residue 
monitoring programs, Commissioner Kennedy said : 

I think it is important to note that there are very significant monitoring ac- 
tivities at the state level, particularly in highly progressive, very forward-looking 
states like California. 

These states collect, together, many more samples than we do, perhaps ten times 
as many in the aggregate. California alone, in fact, collects more than the Food 
and Drug Administration does. 

We have, ourselves, provided exchanges of results and regulatory information 
with state officials. We've provided training methods, manuals, advice on analyti- 
cal methodology . . . , and analytical reference standard materials in an attempt 
to build those state programs. 

They give us, in turn, inspectional and analytical information.^"'^ 

However, the Subcommittee learned that reciprocity between state 
officials and the FDA is, in fact, extremely limited. Only 6 states 
(Maryland, Virginia, Pennsylvania, Delaware, Iowa and Oregon) have 
entered into agreements with the FDA which, according to Commis- 
sioner Kennedy, ''provide for them to investigate illegal residues re- 
ported by USDA to determine their cause and to develop the back- 
ground for whatever regulatory action is warranted." ^°^ 

Later, under questioning from Congressman Marc L. Marks (R- 
Pa.), Commissioner Kennedy said, ''probably we're going to find that 
the states with whom we have agreements are those that have active 
programs." If that is the case, the Subcommittee is forced to conclude 
that FDA-state residue monitoring reciprocity is far more limited than 
necessary to provide an adequate reciprocity program. 

B. ^^ Market Baskef' program 

In testimony before the Subcommittee, Food and Drug Administra- 
tion Commissioner Kennedy described an adjunct FDA residue 
monitoring program, instituted in 1975, which is known as the "total 
diet" or "market basket" survey. The survey, which is conducted 
annually, is based on thirty market basket samples purchased in 
retail stores in various regions of the country. Twenty market baskets 
contain foods eaten by adults and ten are designed to represent the 
diets of infants and toddlers. Commissioner Kennedy explained the 
nature and purpose of the program to the Subcommittee: 

A sample represents the entire 14-day diet — in the case of the adult sample, 
approximately 117 food items of a typical 18-year-old American male in the 
region of collection. 

The foods are prepared as for the table, divided into a dozen food class com- 
posites, and then each composite is analyzed for residue content. These are used to 
determine which food classes contribute the greatest residues to the diet and to 
pinpoint seasonal and regional trends. 102 

The "total diet" survey is riddled with weaknesses, beginning with 
the following shortcomings brought to the Subcommittee's attention 
by Commissioner Kennedy himself in the following statement: 

I [Mr. Kennedy] think that a major deficiency in these programs is the general 
absence of intelligence on actual pesticide usage, production practices, and 
changes in food consumption patterns. i°3 

Commissioner Kennedy further indicated that FDA often does not 
have enough information on the pesticides used on each market basket 

•M Ibid., p. 258. 
'01 Ibid, p. 308. 
i<a Ibid, p. 257. 
><a Id. 



35 

item. This makes it difficult for FDA to know which pesticides are 
present and need to be analyzed. He also a<;reed with the statement 
that FDA may not find what it is seeking because it is not studyinii^ 
all the possible compounds. Therefore, even though the compound 
may be present, it may not appear in FDA's analyses. 

Chairman Moss expressed concern about the practice of using the 
typical diet of a teenaged male as an exclusive representation of adult 
consumption habits, asking Commissioner Kennedy: 

Isn't there a difference in the diet characteristics of the American male and the 
American female? And are we not interested in what the effect might be on the 
female? i"* 

Commissioner Kennedy replied to the Moss queiy : 

I would certainly think we should be., xvlr. Chairman. ^'^^ 

In fact, a Library of Congress report addressing the issue of con- 
sumption patterns in the tJ.S., submitted for the February 14th 
hearing record, points out that consumption habits do vary according 
to such basic factors as age, sex, region of the country, and food 
preference. FDA's market basket survey ignores these variations in 
eating habits, taking into account only dietary discrepancies for 
infants and, in a statistically meaningless fashion, region of the 
country. Thirty ''market baskets" cannot possibly represent vahd 
geographic eating patterns for the entire United States. 

In a letter submitted to the Subcommittee by the General Ac- 
counting Office, GAO's Henry Eschwege offered additional criticisms 
of FDA's market basket or total diet study: 

. . . although the total diet study does test for some heavy metals, it uses the 
same multi-residue detection methods as FDA's pesticide surveillance program 
and, therefore, it will provide information on the same pesticides detected in the 
surveillance program. As we have previously noted, onl}^ up to 107 of the 268 
pesticides for which tolerances have been set will be detected if all six FDA multi- 
residue methods are used. In addition, the total diet study is an information 
gathering program which does not serve as a basis for regulatory action. 1°^ 

The GAG letter also stated: 

... a dozen or more foods are blended together in slurries which are then 
analyzed for residues; violative pesticide residues in a particular food product 
could often escape detection. ^°7 

While the "market basket" program does provide FDA with some 
useful infoiTnation about chemical residues in food, the subcommittee 
concludes that its deficiencies render it useless as a statistical or 
regulatory tool. 

3. FDA FOLLOW-UP OF USDA MONITORING PROGRAM 

The Food and Drug Administration is responsible for investigating 
violations uncovered during United States Department of Agriculture 
(USDA) monitoring for chemical residues in meat and poultry. FDA 
has the authority to mete out criminal penalites to growers who ship 
chemically violative animals to slaughter. It also has the responsibility 
to remove ''adulterated" produce (containing above-tolerance levels 
of chemical residues) from the market. 



iM Ibid, p. 281. 
103 Id. 

i"* Letter from Henry Eschwege, GAO, addressed to Richard Heller, Counsel, subcommittee on Over, 
sight and Investigations dated Feb. 24, 1978. 
»o^ Ibid. 



36 

Between the years 1973 and 1976, USDA reported 3,100 meat 
and poultry chemical residue violations to the FDA. However, the 
Food and Drug Administration only investigated 37 percent of the 
violation cases. From 1975 to 1977, FDA recalled no poultry and pros- 
ecuted no violative growers identified by USDA residue monitors. 

According to General Accounting Office testimony: 

FDA generally issues information letters to growers even if the violation was 
caused by the grower's deliberate misuse of drugs. ^os 

There are several reasons for FDA reticence concerning prosecution 
of violating growers. According to GAO testimony: 

USDA's monitoring program is not designed to enable FDA to develop the 
case histories needed to support stronger regulatory actions [than issuance of 
letters]. FDA officials told us [GAO] that FDA generally will not prosecute a 
grower for the first violation. Because animals sampled under the monitoring 
program are randomly selected it is unlikely that a grower will be sampled fre- 
quently enough to enable FDA to develop a case history.^^^ 

Since FDA has no authority to hand out civil penalties, it appears 
reluctant to impose a criminal penalty on a one time violator of a 
pesticide or drug residue law. If FDA were given the ability to ad- 
minister civil penalties (fines) it can reasonably be assumed that it 
would not be as reluctant to enforce the law against violators. 

Seizures of meat and poultry are rare because, by the time a residue 
violation has been uncovered during USDiV monitoring, it is too 
late to stop sale of the contaminated produce. And because meat 
and poultry are often not identifiable once they have been shipped to 
market, federal recall of violative produce is doubly difficult. 

Finally, concerning FDA's lack of aggressiveness in investigating 
residue violations reported to it by the USDA, Commissioner Kennedy 
told the Subcommittee: 

Our experience has shown us that when analytical results are given to us after 
a certain period of time has elapsed after the sample was taken, that the proba^ 
bility that the follow-up will yield anything is extremely low. 

I think what our people have been doing is to adopt a strategy of pursuing 
•only those violations that constitute a warm trail. ^i" 

Lack of inter-agency program coordination is a serious problem in 
the regulatory effort to control chemical residues in meat and poultry. 
Both Commissioner Kennedy of the FDA and Assistant Secretary 
for Food and Consumer Services of the USDA, Carol Tucker Foreman, 
recognized this and expressed the need for greater FDA-USDA 
program coordination during testimony before the Subcommittee. 

4. SUBCOMMITTEE FINDINGS AND CONCLUSIONS 

The^ Food and Drug Administration is failing to carry out its 
statutorily mandated programs to control harmful chemical resichies 
in food in a manner that provides the American public with adequate 
protection. FDA is charged with the responsibility of monitoring the 
•country's food supply (other than meat and poultiy) for chemical 
residues FDA's monitoring programs are seriously inadequate. 

The Food and Drug Administration also has the duty to remove 
contaminated food fiom the marketj)lace. This it is rarely able to do. 

More specifically, the Subcommittee finds specifically that: 

">* Hearings, supra note 8, p. 100. 
tot Ibid., p. lir)-116. 
110 Ibid., p. 281. 



37 

1. 271 pesticides are approved for use in a<2:nculture and may 
-potentially remain as chemical residues in food. Only 73 of these 
pesticides are detected by FDA's commonly used "multi-residue" 
detection method. While five other multi-residue tests are able to 
detect an additional 34 pesticides, FDA was unable to document the 
extent to which these methods were used. Many other i)esticides 
may be detected in food through the use of '^single residue" detection 
methods. However, FDA refuses to use single residue tests in its 
regular monitoring programs. An alarming number of pesticides 
are considered carcinogens or sus])ect carcinogens. The Food and 
Drug Administration only regularly monitors 30 percent of these 
chemicals. 

2. FDA is rarely able to remove contaminated meat from the 
marketplace before it is sold because residue detection tests used 
by the FDA in its chemical monitoring programs take longer to 
.perform than these products take to move through the marketing 
process. 

3. Analysis of products contained in FDA's ''total diet" or ''market 
basket" survey, which tests thirty "market baskets" of food purchased 
in various regions of the country annually, is not based on knowledge 
of pesticide usage and production patterns and is therefore only mar- 
ginally valuable. The survey is designed to test for chemical residues 
in ty]Mcal diets of adults, infants and toddlers. However, all twenty 
"adult" market baskets are based on a typical diet for a teen-aged 
male, ignoring proven dietary differences attributable to such factors 
as age, sex, and geographic location. 

4. Although FDA Commissioner Kennedy testified that the co- 
ordinated efforts of state health and agricultural officials and the 
FDA substantially increase the effectiveness of FDA's residue 
monitoring, the Subcommittee finds that state and FDA reciprocity 
is, in fact, quite limited. 

5. The United States Department of Agriculture reported 3,100 
residue violations to the Food and Drug Administration for follow-up 
investigation from 1973 to 1976. FDA only investigated 37 percent 
of these cases and few culminated in regulatory action. Because 
FDA has the authority to impose criminal, but not civil, penalties 
on growers who send violative animals to slaughter, it is reluctant to 
prosecute one-time residue violators. 

6. FDA sets tolerances for drugs administered to livestock. For 
Subcommittee findings and conclusions regarding animal drugs, see 
Chapter Two, page 5. 

5. SUBCOMMITTEE KECOMMENDATIONS FOR IMPROVING FOOD AND DRUG 
ADMINISTRATION REGULATORY PROGRAMS CONCERNING CHEMICAL 
RESIDUES IN FOOD 

A. The Subcommittee recommends that Congress: 

1. Consider legislation which would provide the Food and 
Drug Administration with authorit}' to im.pose civil penalties on 
growers who send contaminated animals to slaughter. 

2. Provide FDA with the necessary personnel and funds to 
improve its monitoring programs. 

B. The Subcommittee recommends that FDA: 

1. Substantially increase its surveillance program for chemical 
residues in food. Chemical detection methods should be improved 



38 

to (a) include more substances, and (b) require less time to 
perform. FDA should use all detection methods available to it, 
including selective use of ^'single residue" testing where no alter- 
natives exist, to provide the public with improved protection 
from dangerous levels of harmful chemicals in food. 

2. Base its chemical monitoring program on greater knowledge 
of pesticide and animal drug usage. Knowledge of where and how 
potentially carcinogenic chemicals are used is especially critical 
to an effective monitoring program. Whenever violative levels 
of substances suspecting of causing birth defects or mutations 
are found special intensive monitoring should be commenced. 
Every effort should be made to stop the sale of contaminated 
food. 

3. Improve and expand its ''market basket" surve3^ Changes 
in the survey should include: 

(a) increased knowledge of the chemicals used on each 
product collected; 

(6) analyzing for a larger rate of chemical contaminants; 

(c) controlling for differences in consumption patterns. 
The survey should control for sex, age, and regional food 
preferences. 

4. The FDA should continue its efforts to interest states in 
reciprocal agreements involving agricultural chemical monitoring 
being careful not to withdraw any of its own energies as state 
programs improve. 



Chapter V — General Conxlusiox 

The Subcommittee on Oversight and Investig-ations concludes that 
the federal programs designetl to protect the American public from 
toxic chemicals in food, which are administered jointly by the United 
States Department of Agriculture (USDA), the Enyironmental Pro- 
tection Agency (EPA), and the Food and Drug Administration 
(FDA), are ineffective. In some cases, existing laws need amending. 
(Recommenciations for new legislation are ])resented at the close of 
the three chapters on agency ])rogi'ams.) However, in many more 
instances, the EPA, FDA and USDA are failing to carry out the vital 
responsibiUties invested in them to protect the public from dangerous 
chemical residues in food. These failures are briefly summarized here: 

EPA: The federal chemical residue monitoring system hinges on a 
strong pesticide tolerance setting program. Plowever, the Environ- 
mental Protection Agency's system for setting tolerances (safe, legal 
limits of chemical residues that may be found in specific foods) is 
outdated, ineffectual, and showing few signs of improvement, EPA's 
Office of Pesticide Programs is veering away from the health-oriented 
language of the Federal Food, Drug, and Cosmetic Act, which ad- 
ministers the tolerance setting program, toward the ' 'risk-benefit" 
balancing language of the Federal Insecticide, Fungicide and Rodenti- 
cide Act, under which pesticides are registered for use. In so doing, 
the EPA is putting the public at greater risk. Many tolerances remain 
in effect for pesticides that are knowTi to be suspect carcinogens. Scores 
of other tolerances are for chemicals that have never been tested for 
carcinogenicity or other equally serious effects. 

USDA: The United States Department of Agriculture, which is 
responsible for monitoring meat and poultry for residues of chemicals 
such as pesticides and animal drugs, is doing a poor job of finding 
residue violations and of preventing (in conjunction with the Food 
and Drug Administration) the marketing of contaminated meat. 
The Department's two residue monitoring programs (on the farm and 
in the slaughterhouse) are seriously ineffective. The ''in slaughter- 
house" monitoring program tests few animals and doesn't look for 
many harmful chemicals known to occur in meat and poultry. The 
''pretest" program, which enjoins growers suspected of marketing 
violative livestock to submit tissue samples for laboratory analysis, 
is easily avoided by farmers. Consequently, much of the meat and 
poultry consumed in this country may be contaminated. The USDA 
inspection stamp goes on all produce that has passed inspection for 
risible signs of health and cleanliness. The stamp is no guarantee that 
meat is free of chemical contaminants. 

FDA: I'he Food and Drug Administration's role in the regulation 
of toxic substances in food includes monitoring agricultural ])roduce 
(other than meat and poultry) for residues of pesticides and environ- 
mental contaminants, investigating and prosecuting cases of residue 

(39) 



40 

violations in meat and poultr>" reported to FDA by USDA, and sharino: 
responsibility, with USDA, for keeping contaminated produce out of 
interstate commerce. FDA's chemical monitoring program has dan- 
gerous shortcomings. Many chemicals occurring in food that are 
kno\\Ti to be suspect carcinogens or may potentially cause birth 
defects and genetic mutations are not monitored. FDA investigates 
few of the residue violations reported to it by USDA and rarely 
prosecutes violators. Combined USDA-FDA programs to remove 
contaminated meat from the marketplace almost never result in 
meat or poultry recalls. 

Specific Subcommittee recommendations are detailed at the close 
of chapters 2, 3, and 4. General summaries of recommendations to 
the three agencies are as follows : 

EPA should overhaul its tolerance setting program. Existing 
pesticide tolerances should be reassessed. Those lacking safety test 
and residue data should be revoked unless registrants produce required 
data before January of 1981. 

Tolerances for substances suspected of causing cancer, reproductive 
problems, birth defects and genetic mutations should be revoked, 
no later than July of 1981. EPA should discontinue its practice of 
issuing ''interim tolerances" for pesticides which have not been proven 
safe, or which are suspected of being safety hazards immediately. 

Tolerance exemptions that have been granted over the years 
should be reassessed. Many tolerance-exempt pesticide ingredients 
are suspect carcinogens. The practice of exempting all ''inert" ingredi- 
ents from the tolerance-setting requirement should be curtailed by 
January of 1980 since some inerts are more highly toxic than active 
pesticides. 

Tolerance-setting methodology should be brought up to date with 
current scientific knowledge. EPA's method of computing the 'Food 
Factor" should be based on demographic information about food 
consumption. — ^^ 

fEPA should develop a system for pesticide safety testing which 
removes testing from the manufacturers' own labs and places it in 
the hands of independent, impartial laboratores. Such a system could 
include Federal licensing of independent laboratories and Federal 
monitoring of these laboratories to assure objectivity^ 

Positions devoted entirely to reassessment and overhaul of tlie 
pesticide tolerance setting system should be created and filled within 
EPA's Oflice of Pesticide Programs. 

USDA should allocate additional resources and personnel to its 
chemical residue monitoring programs. Rapid test procechires for 
chemicals known to occur as residues in meat and poultr}' should be 
developed on a high priorit}^ basis. The percentage of animals randomly 
tested for chemical residues in slaughterhouses should be increased, 
and where "multi-residue" test methods do not exist, USDA should 
use "single-residue" methods selectively. 

A national identification system for livestock should be developed 
so that growers will not be able to evade USDA's "pretest" chemical 
residue monitoring j^rogram. 

FDA should ex|)and its residue monitoring program (for foods other 
than meat and poultry) substantially. Chemical detection methods 
should be improved to include more substances and require less time 
to perform. Where "multi-residue" tests are lacking, "single-residue'*' 
methods should be used on a selective basis. 



41 

Chemical residue monitorin<2: should be based on a knowledire of 
where particular residues are likely to occur. Residue violation findintrs 
should be backed up by strong efforts to remove contaminated produce 
from the market. 

FDA should improve its ''market basket" survey, based on knowl- 
edge of consumption habits and chemical usage. 

FDA should continue its efforts to integrate state-federal chemical 
monitoring efforts. 

In addition to presenting specific agency recommendations at the 
close of chapters 2, 3, and 4, the Subcommittee also recommends that 
the U.S. Congress take action to improve the federal system for 
monitoring toxic pesticides in food. Recommendations to Congress 
are summarized here as follows: 

Congress should consider passing legislation making it unlawful to 
use potentialh^ carcinogenic, teratogenic ^^^ or mutagenic ^'^ ])esticides 
on agricultural commodities, unless such substances degrade and 
leave no harmful metabolites in food. 

Congress should consider livestock quarantine legislation, giving the 
United States Department of Agriculture the authority to detain 
from slaughter all animals suspected of containing violative chemical 
residues, pending laboratory test results. 

Congress should give the Food and Drug Administration the 
authority to imj^ose civil penalties on growers who send livestock 
contaminated with residues of animal drugs or pesticides to slaughter. 

Overall, the Subcommittee recommends that all three agencies 
responsible for protecting the public against chemically contaminated 
food, the EPA, FDA and USDA, strive for increasingly effective 
programs improved research and development, greater inter-agency 
CQardiaation, and a heightened aw^areness of tTie'need to i)rotecT"' 
the public from unecessary exposure to harmful chemicals in food. 



"1 Teratogenic is defined as the quality of a substance to induce birth defects by acting on the embrya 
"2 Mutagenic is defined as the quality of a substance to produce permanent, hereditary genetic changes 



SEPARATE VIEWS OF THE HONORABLE 
JAMES M. COLLINS 

I have deep and serious disafj^reements with this report. As I read 
this report, the message that comes throuf2:h is that what is bein^^ 
advocated here is a ''no risk" or ''Delaney" type standard with respect 
to pesticide regulation. Such a standard is, of course, impossible, and 
Congress when enacting the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) clearly recognized this fact. 

Let me first say that I, of course, want to protect the public health 
as much or more than anyone else, but I do not believe that greatly 
eliminating food from the diet is the answer which is precisely what 
would happen if the Subcommittee Report's "no risk standard" was 
ever adopted. Pesticides are absolutely essential to this nation's basic 
food supply, but they are, after all, poison designed to kill. Chemicals 
powerful enough to perform this task almost by definition pose some 
risk. What we must do is take into account the enormous advantages 
of pesticides as well as their risks which is exactly the FIFRA standard 
and the EPA mandate. 

I truly wished that we lived in a world where chemicals of this sort 
did not have to be used to produce a food crop, but we do not. That 
being the case pesticides will quite simply have to be used, but with- 
all possible precaution taken to preclude serious adverse effects to 
humans. I, thus, find the Subcommittee's report on this to be a case 
of well meaning though inflammatory rhetoric, but lacking in serious 
thought. 

A case in point is the report's criticism of the EPA's Office of 
Pesticide Program's for balancing the requirements of the Food, Drug 
and Cosmetic Act (FDCA) with the requirements of FIFRA. After 
all does that not have to be the case, due to the fact the FIFRA 
recognizes that there are risks associated with the use of pesticides 
but that these risks must be balanced against the benefits of pesticides. 
An absolutist approach is simply not feasible. The Subcommittee 
Report views FIFRA as being somehow at odds with FDCA with 
FIFRA being less health oriented. I just do not see it that way. I see 
the two acts as complementary approaches to the same problem of 
how to deal with the acknowledged risks of many pesticides. I do not 
see one act as being more health oriented than the other. 

The issue here is how best to get at the real concern of dealing with 
the risks. Tolerance setting is one approach and registration of pesti- 
cides is another. If registration is effective then tolerance setting will 
be greatly aided, but if registration is ineffective then so will tolerance 
setting. I, thus, believe that EPA's emphasis on registration is prudent, 
and more potentially efficacious. The EPA as the Subcommittee 
Report notes is making progress in the area of registration. 

James M. Collins. 
(43) 



APPENDIX I 

LIST OF 36 FAInTX)MLY SAilPLED ^ 
PESTICIDE CHE>nCALS AI>ID REQUIRED 
DATA NOT AVAILABLE TO SLTPORT TOLERAjgCES 



Chemicals 



Cancer or 
other tujTiors 



Reproductive 
effects 



Birth 
Defects 



C-ene 
Mutations 



Aldrin 



Allethrin 




X 


X 




Atrazine 






X 


X 


Benefin 


X 


X 


X 


X 


Captan 2/ 


Carbaryl 2/ 


Carbophenothion 






X 


X 


Chlordane 


2, 4-D 


Dala^n, Sodium Salt 








X 


DDVP 2/ 


Diazinon 








X 


Dimethyl arsinic Acid 


X 


X 


X 


X 


Diuron 






X 


X 


Endosulfan 


Endrin 1/ 






X 


X 


Ferbam 




X 


X 


X 


Guthion 








X 


Lanstan 


X 


X 


X 


X 


Lindane 1/ 


Malathion 








X 


Methoxychlor 


X 




X 


X 


Methyl Parathion 


X 








Norea 








X 


Paraquat 2/ 








X 


Parathion 


Piperonyl Butoxide 2/ 








X 


Pyrazon 








X 


Pyrethrins 


Rogor 








X 


Ronnel 






X 




Silvex 




X 




X 


Sodium Trichlor acetate 


X 


X 


X 


X 


Thiodemeton 


X 




X 


X 


Thiram 




X 


X 


X 


Zineb 








X 



1/ Currently undergoing RPAR review. 
2/ Being considered for RPAR review. 



14 



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48 



NUMBER OF FOOD SA.MPLES ANALYZED WITH 

METHODS OTHER THAN FDA'S COl-H-IONLY 

USED MULTIRESIDUE METHOD (FISCAL YEAR 1977) 

1. Mirex and HCB (milk, eggs, root crops) 

2. Triazines (com, forage, friuts) 



3. Kepone (fish) 

Kepone and Mirex (fish) 

4. Dibromochloropropane (DHCP) 

and ethylene dibromide (EDB) 

5. Organophosphate, Organonitrogen, 

Organochlorine, Hydrocarbon 
(imported fruits and vegetables) 



1A4 

96 

168 
132 



564— 



1,334 (approx. ) 
2.438 



1/ These samples were analyzed over both fiscal year 1977 
and 1978. 



49 



APPENDIX II 



RPAR'a ISSUED 



SPEX:iAL PESTICIDE REVIEWS DIVISION 
STATUS REPORT 



April 17, 1978 



aiEMICAL(Class of 

Cliemlcals) and 40 CFR 162.11 CRITERIA 

PROJECT MANAGER POSSIBLY MET OR EXCEEDED 



DATE OF FR 
PUBLICATION 



OOMMEtTT PERIOD POST RPAR 
CLOSING DATE STATUS 



BAAM (AMITRAZ) 
Jeff Kenpter 
755-8053 



Oncogenicity in mice. 



4/6/77 



BENOMYL Reductions in non-target species 12/6/77 
Esther Saito (earthwornB);mutagenicity(itultitest); 
755-8050 teratogenicity in rats; reproductive 
effectsCspermatogenic reduction in 
rats); hazard to wildlife (aquatic 
organisms). 



7/18/77 



3/24/7 B 



Awaiting CAG 

rebuttal 

analysis 

Rebuttal 
padcage in 
OPP 



BlIC 

Franlc Parsons 

755-5851 



Oncogenicity, fetotoxicity 
and reproductive effects in 
mice and rats. 



CADMIUM Oncogenicity in humans (epidemio- 
Richard Troast logical data); mutagenicity 
755-8050 (nultitest); teratogenicity, 

fetotoxicity and metabolic effects. 



10/19/76 



10/26/77 



11/19/76 



2/10/78 



Converted to 

Lindane 

products 

Rebuttal 
package in 
OPP 



aiLOROBENZILATE 
Joe Boyd 
755-5632 

aiLOROEORM 
Alma Shea/ 
Anthony Inglis 
755-8050 



Oncogenicity in mice. 



Oncogenicity in mice and rats; 
possible liver and jtidney 



5/26/76 



4/6/76 



8/30/76 



7/23/76 



TOP PRIORITY 
PD 2 S. 3 to 
be combined 

Supplemental 
RPAR being 
prepared 



DBCP 

Jeff Kenpter 

755-8053 



DIALLATE 
Richard Troast 
755-8050 



Oncogenicity in mice and rats; 
reproductive effects in test 
animals and possibly in humans. 



Oncogenicity in mice and rats. 



9/22/77 



5/31/77 



11/7/77 



9/9/77 



Awaiting 
CED reviews; 
Final PD be- 
ing drafted 

Awaiting CAG 

rebuttal 

analysis 



50 




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61 



APPENDIX III 

EPA assumes that no more than 7.5 ounces of the 
following food items are consumed per person per year 

Almonds Mangoes 
Artichokes Millet 
Avocados Milo 
Barley Mollasses 
Beet Greens Mushrooms 
Blackberries Muskmelons 
Black-eyed Peas Nectarines 
Boysenberries Okra 
Blueberries Papayas 
Brussel Sprouts Parsley- 
Buckwheat Parsnips 
Casaba Melons Passion Fruit 
Chicory Pawpaws 
Coconut Pecans 
Crabapples Peppermint 
Cranberries Persian Melon 
Cranshaw Melons Pimentos 
Currants Plums 
Dates Quinces 
Dewberries Radishes 
Eggplant Rasberries 
Elderberries Rutabagas 
Escarole Rye 
Figs Safflower 
Filberts Salsify 
Garlic Shallots 
Gooseberries Sorghum 
Greens Spearmint 
Hominy Sugar Beet Tops 
Honeydew Melons Summer Squash 
Honeyballs Sunflower 
Hops Swiss Chard 
Horseradish Tangelos 
Huckleberries Tangerines 
Jerusalem Artichokes Taro 
Kale Turnip Greens 
Kohlrabi Turnips 
Kumquats Walnuts 
Leeks Watercress 
Loganberries Winter Squash 
Macadamia Nuts Youngberries 



62 

APPENDIX IV 
THE INVESTIGATION AND CLASSIFICATION 

OF INERT INGREDIENTS IN PESTICIDE FORMULATIONS 
^ (EXCERPTS) 



Submitted to 



Criteria and Evaluation Division 

Office of Pesticide Programs 

Environmental Protection Agency 

Washington, D. C. 



FINAL REPORT 

SEPTEMBER 30, 1977 
EPA Contract 68-01-3431 



Submitted by: 

POTOMAC RESEARCH, INCORPORATED 
7655 Old Springhouse Road 
Westgate Research Park 
McLean, Virginia 221 01 



63 



Toxicological Gassificalion 

As data was collected on individual compounds, the inerts were toxicologically evaluated. 
Following a professional review of available literature, the inerts were categorized as: 

Class 1 This category of inerts contains those found to have chemical, toxicclogical 

or environmental characteristics that require immediate attention. 

Class 2 Available data indicate probable cause for alarm because chemical structure is 

similar to a known toxicant, or a metabolic environmental pathway may result 
in breakdown to known toxicant, or irreversible chronic effects are known, e.g., 
neurotoxicity, irreversible eye damage, skin sensitization, etc. Massive fish kills 
or other environmental effects also triggers this category. 

Gass 3 Hazard data inadequate for total review where it is apparent that the use of the 

inert would indicate certain test requirements. 

Qass 4 No hazard data found or complete testing published i.e., ideal situations. 

Class 5 Natiire of inert does not allow chemical definitions, i.e., manure, corn, rotten eggs, 

etc.; however, it is reasonable to assume no hazard exists. 

Oass 6 Miscellaneous Class — errors in number or name; the name could not be properly 

identified, number incorrect, incorrect classification, etc. -a 

Listed in Table 3 are those compounds which were assigned a Class 1 or 2 hazard classification. 



64 



CLASS 1 AND : COMPOUNDS 



EPA 
Accession Hazard 

Number Compound Name Class 

419 Phenarsazine oxide 

623 Dimethylamine 

692 Hydroxylamine Sulfate 

695 Lead 

734 2-lmidazolidinethione 

766 Dioxane 

781 Saccharin 

914 2-Ethylhexanoic acid, nickel salt of 

83 Diethanolamine oleate 2 

272 7-Hydroxy-4-methylcoumarin 2 

298 13-Dibutyl-2 -thiourea 2 

308 alpha, beta-Epoxy-beta-methylhydrocinnamic add, ethyl 

ester of 2 

3 1 6 Dichloroanilime 2 

332 Tris (2-Butoxyethyl) phosphate 2 

343 l-Methyl-2-pyrrolidene ^2 

433 Citric acid, tris (triethylamine) salt of 2 

435 Citric acid, tris (dimethylamine) salt of 2 

455 Ethylenediaminetetraacetic acid, tetrakis (triethylamine) salt of 2 

461 Ethylenediaminetetraacetic acid, tetrakis (diethanolamine) 

salt of ,2 

571 Triethylamine phosphate -^ 2 

595 7-{Diethylamino)-4HTiethylcoumarin ^ 2 

706 Diethylenetriamine 2 

724 l-Amino-2-propanol nitrite 2 

736 1,3-Diethy 1-2 -thiourea 2 

75 1 Lead chromate 2 

752 N, N'-Dinitrosopentamethylene tetramine 2 

753 Dicyanodiamide 2 
777 Propylamine nitrite 2 
795 Nitromethane * 2 
843 Nitrilotriacetic add, tris (triethylamine) salt of 2 
850 Aniline 2 
882 Triethyl phosphate 2 
895 Hexane 2 

898 Nonylphenol, barium salt of 2 

899 Toluic add, cadimun salt of 2 
941 N-Ethyltoluenesulf on amide 2 
976 1 , 2-Eposybutane 2 
981 Alpha, alpha-Dimethylbenzyl hydroperoxide 2 
983 Atropine 2 



34 



65 



CLASS 1 AND 2 COMPOUNDS - Continued 



EPA 






Accession 




Hazard 


Number 


Compound Name 


Gass 


1001 


Maleic anhydride 




1007 


Dimethyl ether 




1009 


2, 4, 6-Trinitrophenol, sodium salt of 




1034 


2, 2' - (Ethylamino) diethanol 




1039 


Diisopropanolamine 




1069 


Acetonitrile 




1070 


1,2, 3-Benzotriazole 




1085 


Triethylamine 




1093 


2-Nitropropane 




1116 


Triethylamine Sulfate 




1132 


3, 4-Epoxycyclohexanecarboxylic acid, (3, 4-epoxycyclohexyl) 






methyl ester of 




1193 


tert-Butyl peroxide 




1210 


Dibutyldithiocarbamic acid, zinc salt of 





35 



POTOMAC RESEARCH. IMCORPORATEO 



66 



EXCERPTS 



"INERT INCRtinni.-TS OF I'KST lCH>r. ror.-'.U'^ATlON'D" Korni.n: 

(FOIIMAT FOR IDLN'l IFICATION AND lOXJCOLOCICAL APPRAISAL) 1 

A. EPA Accession Number and Name; 
000766 Dioxane 

B. American Chemical Society Chemical Abstracts Service (CAS) Name and 
Registry Number 

l,A-Dioxane 
123-91-1 

C. Other Names 

(S): Diethylene dioxide; l,<i-Diethylene dioxide; Diethylene ether; 
di (Ethylene okide); l,A-Dioxacyclohexane; Dioxan; l,A-Dioxan; 
para-Dioxan; Dioxane; para-Dioxane; Dioxyethylene ether; Glycol 
ethylene ether; Tetrahydro-l,A-dioxin; Tetrahydro-para-dioxin 

D. Chemical Composition 

C4-H8-02 
(MW) 88.10 



6. Chemical and Physical Properties (1) 



Use ar. an Inert - solvent, cosolvent (17) 



1. Other Uses Active? Yes ( ) No (X) 

Stabilizer in chlorinated solvents. Solvent for cellulose acetate, 
ethyl cellulose, benzyl cellulose, resins, oils, waxes and some dyes, 
and as a solvent for electrical, agricultural and biomedical inter- 
mediates and for adhesives, sealants, cosnetics, pharmaceuticals, 
rubber chemicals and surface coatings. (1^) 

J. Government Regulations 

1. FDA - 21 CFR 121.2520 - Can be used as a component of adhesives 
used in packaging, transporting or holding food. (16) 

2. EPA - AO CFR 180.1001 - Exempted from a* tolerance requirement when 
used in accordance with good agricultural practice as an inert 
Ingredient in pesticide formulations applied to growing crops 
only. (17) 

3. OSHA - 29 CFR 1910.1000 - U.S. Occupational Standard 

Skin: 100 ppm or 360 mg/ra3 on a time weighted average. (TWA) (15) 



DOT - A9 CFR 172.101 - Hazard class: Flammable liquid 

Label required: Flammbale liquid (18) 



67 



L. Environment 



M. Toxicology 

1. Human effects 



Occupational Studies - Exposure of 12 volunteers to a concen- 
tration of 1080 mg/m3 (300 ppm) l,A-dioxane vapor in air for 
15 minutes produced irritation of the eyes, nose and throat. (6) 
One week's exposure to 500 ppm l,A-dioxane resulted in the ~ 
Jeath of one worker; autopsy revealed kidney, liver and brain 



damage. (7) 



Poisoning Incidents and Case Studies - 5 acute deaths due to 
l,A-dioxane exposure have been reported; hemorrhagic nephritis 
and liver necrosis were recorded at autopsy. (8) 



2. Non-Human Mammalian Effects ♦ 

a. Acute toxicity - The i.p. LD of l.A-dioxane in male Sprague- 

Dawley rats was 5.6 g/kg. (2) The oral LD's in mice, rats and 
guinea pigs were 5.7, 5.2, and 3.9 g/kg respectively. (3) 



Absorption/Excretion - In male rats given single oral doses of 
10, 100 or 1000 TOg/kg lAC-1, A-dioxane, excretion of unchanged 
1,4-dioxane in expired air was 0.0A3 mg/kg (0.43%) at the lowest 
dose and 252 mg/kg (25%) at the highest dose. (5) 



Subacute - In mice, rats, guinea pigs and rabbits subjected to 
repeated 1.5-hour exposures to 3600 rag/m3 (1000 ppm) l,A-dioxane 
in air (total exposures, 78-202.5 hours), vascular congestion of 
the liver and degenerative changes in the renal cortex were 
observed. (4) 



68 



Carcinogenicity - l,A-dioxane is carcinogenic in rats and guinea 
pigs by oral administration: it produced malignant tumors of 
the nasal cavity and liver in rats ^nd tumors of the liver and 
gall bladder in guinea pigs. It was also active as a promoter 
in a two-stage skin carcinogenesis study in mice. No carcino- 
genic effect was observe! in one inhalation study of rats." 
(1) See (2). (9) - (U), as cited in (1) 



N. Recommendation: Class 1 

Human deaths from accidental poisoning through inhalation and skin 
absorption of 1,^-dioxane have been reported. The cause of death 
appeared to be liver, kidney and brain damage. These findings have 
been supported by studies in rodents. More importantly, 1,^-Dioxane 
has been shown to be carcinogenic in mice, rats, guinea pigs by both 
oral and inhalation routes of administration. Consequently, the use 
of 1,4-Dioxane as an inert ingredient in pesticide formulations should 
be discontinued in all new production batches. 

0. Sources used in Search 



On Line Data Bases 



2. Major References 



a. Toxline 

b. Medline 

c. Cheraline 

d. Other 



a. The Merck Index 

b. NIOSH Registry of Toxic Substances 

c. Chemical Abstracts 

d. -Biological Abstracts 

e. Other 



References and Review Articles 



) U.S. Environmental Protection Agency, Office of Pesticide Programs, 

Acceptable Common Names and Chemical Names for the Ingredient Statement 
on Pesticide Labels , U.S. G.P.O., Washington, D.C.: 1975. 

) Chemical Rubber Publishing Co., Handbook of Chemistry and Physics , 
57th Ed., Cleveland, Ohio: 1976-1977. 

) Condensed Chemical Dictionary , 8th Ed., Van Nostrand-Rheinhold Co., 
New York: 1971. 

) Merck and Co., The Merck Index , 9th Ed., Rahway, N.J.: 1976. 

) National Institute of Occupational Safety and Health, Registry of 
Toxic Effects of Chemical Substances , U.S. G.P.O., Washington, 
D.C;: 1976. 

) Association of American Pesticide Control Officials, Inc., Pesticide 
Chemical Official Compendium , Topeka, Ks. 

) Farm Chemicals Handbook , Melster Publishing Co., Willoughby, Ohio: 1975. 

) McCutchcons Detergents and Emulsifiers , Allured Publishing Co., 
Ridgewood, N.J.: 1973. 

) U.S. Food and Drug Administration, Department of Health, Education & 
Welfare, GRAS Monograph Series . 

[1) World Health Organization, lARC Monographs on the Evaluation of 
Carcinogenic Risk of Chemicals to Man ; 11 , pp 247-255, Geneva, 
1976. 



69 



p. Rcfcrcncc-s and Review Articles (cont.) 

(2^) Argus, M.F.; R.S. Sohal; CM. Bryant; C. Iloch-Lictt i ; J.C. 

Arcos, Dose-response and ultrastructural alterations in diox.me 
carcinogenesis, Influence of mcthylcViolanthrcmc on actue toxicity, 
Europ. J. Cancer ; 9. pp 237-243, 1973. 

(3) Laug, E.P.; H.O. Calvery; H.C, Morris; and G. Woodard, The toxi- 
cology of some glycols and derivatives, J. Industr. Hyg. Toxicol. ; 
21, pp 173-201, 1939. 

(it) Fairley, A.; E.G. Linton; A.H. Ford-Moore, The toxicity to 

animals of 1:A dioxan, J. Hyg. (Lond.) ; 34 , pp 486-501, 1934. 

(5) Young, J.D. and P.J. Gehring, The dose-dependent fate of 1,4- 
dioxane in male rats, Toxicol. Appl. Pharmacol. ; 33 . p 183, 
1975. 

i6) Silverman, L. ;. H.G. Schulte; W.W. First, Further studies on 

sensory response to certain industrial solvent vapors, J. Industr. 
Hyg. ; 28, pp 262-266, 1946. 

(T) Johnstone, R.T., Deatn due to dioxane?, AMA Arch. Industr. Hlth. ; 
20, pp 445-447, 1959. 

(8^) Barber, H. , Haeraorrhagic nephritis and necrosis of the liver from 
dioxan poisoning, ^uy's Hospital Rep. ; 84 , pp 267-280, 1934. 

i9) Argus, M.F.; J.C. Arcos, and C. Hoch-Ligeti, Studies on the car- 
cinogenic activity of protein-denaturating agents: hepatocarcino- 
genicity of dioxane, J. Nat. Cancer Inst. ; 35 , pp 949-958, 1965. 

(10 ) Hogh-Ligeti, C. and M.F. Argus, Effect of carcinogens on the lung 
of guinea pigs . In: Nettesheira, P; M.G. Hanna, Jr. and J.W. 

- Deatherage, Jr., eds. Conference on the Morphology of Experimental 
Respiratory Carcinogenesis. Gatlinburg, Tenn. , 1970 , AEG Symposium 
Series Nb. 21, Springfield, Va. , National Technical Information 
Service, pp 267-^79, 1970. 

(11) Hoch-Ligeti, C.; M.F. Argus; J.C. Arcos, Induction of carcinomas 

in the nasal cavity of rats by dioxane, Brit. J. Cancer ; 24 , pp 164- 
167, 1970. 

(12) Kociba, R.J.; S.B. McCollister; G. Park; T.R. Torkelson; 

P.J. Gehring, 1,4-Dioxane. I. Results of a 2-year ingestion study 
in rats, Toxicol. Appl. Pharmacol. ; 30, pp 275-286, 1974. 

(13) Torkelson, T.R.; B.K.J. Leong; R.J. Kociba; W.A. Richter; and 

P.J. Gehring, 1,4-Dioxane. II. Results of a 2-year inhalation study 
in rats, Toxicol. Appl. Pharmacol. ; 30 , pp 287-298, 1974. 
(lA) King, M.E.; A.M. Shefner; and R.R. Bates, Carcinogenesis bioassay 
of chlorinated dibenrodioxins and related chemicals, Environm. 
Hlth. Persp. ; 5, pp 163-170, 1973. 

(15) U.S. O.S.H.A., Code of Federal Regulations ; 29, part 1910.1000, 
Washington, D.C.: 1976. ■ 

(16) U.S. F.D.A. , Code of Federal Regulations ; 21, part 121.2520, 
Washington, D.C.: 1976. 

(17) U.S. E.P.A. , Code of Federal Regulations ; 40 , part 180.1001, 
Washington, D.C.: 1976. 

(18) U.S. D.O.T., Code of Federal Regulations ; 49 , part 172.101, 
Washington, D.C..: 1976. 



70 



"i!;i:i'.T inck::i)1!;:;ts or i^KSTicini: roiL-xiy»Tio:;s" For;...! 

(FORMAT ]-0R IDEJ^T] FICATION' AND TOXICOLOCICAL API'I^AISAL) 1 

EPA Accession Nunbcr and Name: 
000A19 Phenarsazine oxide 



C. Other Names 



(S): Phenazarsine oxide 

D. Chemical Composition 
(C12-H9-As-N)2-0 



G. Chemical and Physical Properties - No specific information could be found 
on phenarsazine oxide. The information given applies to general arsenical 
compounds. 



Use as an Inert 



Other Uses Active? Yes ( ) No (X) 

This substance is very similar in structure and composition to phenarsazine 

chloride, which is used as a var gas. (5) 



OCHA - 29 CFR 1910. 1000 - U.S. Occupational Standard for arsenic and 
arsenic compounds 0,5 ng As/ra3. (M 



71 



M. Toxicology 

1. Human effects 



a. Occupational Studies - Clinical reports have documented an 
association of chronic arsenicism with skin cancer in vineyard 
workers. The risk of lung cancer is clearly increased in cer- 
tain smelter workers who inhale high levels of inorganic arsenic 
compounds. O) 

b. Epidemiology - Phenarsazine chloride is used as a war gas and 
in combination with tear gas. It produces a watery nasal dis- 
charge; severe pain in the nose, sinuses, chest; sneezing, cough- 
ing, nausea, vomiting, depression, weakness and sensory distur- 
bances. (_5) 

c. • Metabolic Effects Studies - In all cases of arsenic poisoning, 

it is the ion of arsenious acid, rather than the element itself 
which produces the toxic effects. The in vivo conversion of it 
to arsenite explains why all chemical forms of arsenic eventually 
produce the same toxic syndrome. As arsenite, the element is an 
active enzyme inhibition, presumably because of its attachment to 
sulfhydryl groups of essential proteins- {1) 

d. Poisoning Incidents and Case Studies - Absorbed arsenic is excreted 
largely by the kidneys, but feces, skin and hair sometimes contain 
appreciable amounts. {1) 

Inhalation TCLo: 19 mg/m3/3 minutes produced irritation, inhalation 
LC50: 30 gm/kg, inhalation LCLO: 5A ppm/30 minutes (all inhalation 
data is for phenarsazine chloride) . (2^) 

e. Others - Trivalent organic arsenicals such as jhonylarsenoxide 
are more potent inhibitors of certain sulfhydrylenzymes than 
are inorganic arsenites. (1^) 

Ncin-llui!.:in Maiumalian LHucls 

a. Acute toxicity - Inhnlation, 1.U30*: rat, 1^ mg/kr,; guinua 
pig, 2. A mg/kg; Intravenous, 1.D50: .mbbit, 6 m^/kg (all 
for phenarsazine chloride) (2^) 



N. Rccommcndat ion : Class 1 

The evidence is now ovcrwliclming that arsenic is a carrinogm in nmn. 
Because of the ubiquitous occurrence of arsenic ,' contamination must be 
kept to a minimum consistent with the background in any particular area. 
Consequently, added arsenic in any form should be avoided in all 
pesticide formulations. 



0. Sources used in Search 

1. On Line Data Bases 2. Major References 

a. The Merck Index 

b. KIOSH Registry of lo::ic Suustrr 

c. Chemical Abstracts 

d. biological Abstracts 

e. Other 



a. 


Toxline 


b. 


Medline 


c. 


Chemline 


d. 


Other 



72 



p. References and Review Articles 

( ) U.S. Environmental Projection Agency, Office of Pesticide Programs, 

Acceptable Common Names and Chemical Names for the Ingredient Statement 
on Pesticide Labels , U.S. G.P.O., Washington, D.C.: 1975. 

( ) Chemical Rubber Publishing Co. , Handbook of Chemistry and Physics , 
57th Ed., Cleveland, Ohio: 1976-1977. 

( ) Condensed Chemical Dictionary , 8th Ed., Van Nostrand-Rheinhold Co., 
New York: 1971. 

(_5) Merck and Co., The Merck Index , 9th Ed., Rahway, N.J.: 1976. 

(2^) National Institute of Occupational Safety and Health, Registry of 
Toxic Effects of Chemical Substances , U.S. G.P.O., Washington, 
D.C: 1976. 

( ) Association of American Pesticide Control Officials, Inc., Pesticide 
Chemical Official Compendium , Topeka, Ks. 

( ) Farm Chemicals Handbook , Meister Publishing Co., Willoughby, Ohio: 1975. 

( ) McCutcheons Detergents and Emulsifiers , Allured Publishing Co. , 
Ridgewood, N.J.: 1973. 

( ) U.S. Food and Drug Adihlnistration, Department of Health, Education & 
Welfare, GRAS Monograph Series . 

O) World Health Organization, lARC Monographs on the Evaluation of 
Carcinogenic Risk of Chemicals to Man , Geneva. 

I'. : . ft-ri riccr, ;;•. J iwjtw Ariiclis (tu:U.) 



(1) Clcai.on, M.N. et al. Clinical To>:irolo{^'.y of Commcrcin) Products , 

Williams and Wilkins, baltinorc: 1969. 
(A) U.S. O.S.H.A., Code of Ic-dcral llcgu]alions ; 29, part 1910. lOCO, 

Washington, D.C: 1976. 



73 



"INERT INGREDIENTS OF PESTICIDE FORI-TULATIONS" Format 

(FORMAT FOR IDENTIFICATION AND TOXICOLOCICAL AITRAISAL) I 

A. EPA Accession Number and Name: 
001085 Triethylaraine 

B. - American Cheniical Society Chemical Abstracts Service (CAS) Nan-.e and 

Registry Number 

Ethanamlne, N, N-diethyl- 
121-A4-8 

C. Other Names 
(f) : TEN 



Chemical Composition 

(C2 H5)3N 
(MW) 101.19 



Other Uses Active? Yes ( ) No (X) 

in the preparation of quaternary ammonium conipcunds (1) 



L. Environment 

1. Effect - Aquatic Toxicity Rating - TLm 96: 100-10 ppm (2_) 

Triethylamine was found to be produced naturally by Streptococcus 
lactis. (10) 



M. Toxicology 



74 



Metabolic Effects Studies - Short-term inhalation of triethylacine 
by humans disrupted central nervous system activity. (9) 



2. Non-Human Mammalian Effects 

a. Acute toxicity - Oral, LD50: rat, A60 mg/kg; mouse, 5A6 ng/kg; 
Inhalation, LCLo: guinea pig or rat, 1000 ppm/A hours; Skin, 
LD50: rabbit, 570 mg/kg (2^) 

b. Pharmacology - Short and long-term inhalation of triethylamine 
vapors disrupted cerebrocortical activity, porphyrin meta- 
bolism, and increased blood cholinesterase activity. (9^) 



d. "Metabolism - In fatal doses to rats, triethylamine was found 
to significantly inhibit the enzymic activity of monoamine 
oxidase in the liver and brain. (11) 



h. Mutagenicity - Triethylamine inhaled by rats at 1 mg/m3 for 
3 months, induced an 18%-24% frequency of aneuploid cells in 
the bpne marrow, compared with O'i-2% in controls. (8^) 

i. Carcinogenicity - Nitrosamines are produced when triethylamine 
reacts with nitrous acid. (7) 



75 



a. 


Toxline 


b. 


Medline 


c. 


Chemline 


d. 


Other 



N. Recommendation : Class 2 

While triethylamine in and of itself is a rr.oderately toxic conpound as an 
inert ingredient in pesticide formulations, use levels could be devised that 
would pose no hazard to aninal and hunan health. However, under certain 
circumstances, triethylaniine can react with nitrites to produce a highly 
potent carcinogen, the corresponding nitrosoamine. An example using morpr.o- 
line along with nitrites in the diet with a consequent high frequency of 
• tumor porduction has been the subject of several publications. The con- 
troversial addition of nitrites to bacon and sausages is another example. 
Because of the inherently explosive publicity that could be generated by 
others, it would be highly desirable for EPA to have investigations underlay 
to determine the circumstances that could lead to nitrosoamne production froi 
triethylamine. 

0. Sources used in Search 

1. On Line Data Bases 2. Major References 

a.' The Merck. Index 

b. NIOSH Registry of Toxic Substances 

c. Chemical Abstracts 

d. Biological Abstracts 

e. Other 

P. References and" Review Articles 

( ) U.S. Environmental Protection Agency, Office of Pesticide Programs, 

Acceptable Common Names and Chemical Names for the Ingredient Stater.ent 
on Pesticide Labels . U.S. G.P.O., Washington, D.C.: 1975. 

O) Chemical Rubber Publishing Co. , Handbook of Chemistry and Physics , 
57th Ed., Cleveland, Ohio: 1976-1977. 

( ) Condensed Chemical Dictionary , 8th Ed., Van Nostrand-Rheinhold Co., 
New York: 1971. 

il) Merck and Co., The Merck Index . 9th Ed., Rahway, N.J.: 1976. 

(2^) Nartional Institute of Occupational Safety and Health, Registry of 
Toxic Effects of Chemical -Substances , U.S. G.P.O. , Washington, 
D.C.: 1976. 

( ) Association of American Pesticide Control Officials, Inc., Pesticide 
Chemical Official Compendium , Topeka, Ks. < . 



( ) U.S. Food and Drug Administration, Department of Health, Education S 
Welfare, GRAS Monograph Series . 

( ) World Health Organization, lARC Monographs on the Evaluation of 
Carcinop,cnic Risk of Chemicals to Man, Qoneva. 



76 



p. References and Review Articles (cont.) 

(4_) Oil, Paint and Drug Reporter, OPD Chemical Buyers Directory , 

Schnell Publishing Co. , New York: 1974. 
(_5) U.S. O.S.H.A., Code of Federal Regulations ; 29, part 1910.1000, 

Washington, D.C.: 1976. 
(6^) U.S. D.O.T., Code of Federal Regulations ; 49, part 172.101, 

Washington, D.C. : 1976. 
(7_) Schweinsberg, F. and J. Sander, Carcinogenic nitrosamines from 

simple aliphatic tertiary amines and nitrite, Hoppe-Seyler' s Z 

Physiol. Chem. ; 253(11). pp 1671-6, 1972. 
(8^) Isakova, G.K. et al, Mutagenic action of chemical substances in sub- 
stantiation of 'hygienic standards, Gig. Sanit. ; 36.(11). PP 9-13, 1971. 
(9) Tkacher, P.O., Hygienic assessment of the effect of inhalation of 

small concentrations of aliphatic ethylamines, Gig. Sanit. ; 36(11) , 

pp 8-11, 1971. 

(10 ) Golovnya, R.V. et al, Synthesis of aliphatic amines by lactic acid 
bacteria, Biokhiaiya ; 3^(.^) , pp 853-60, " 1969. 

(11 ) Valiev, A. , Effect of some aliphatic amines on monoamine oxidase activity 
in rats, Farmakol , Toksikol; 31(2), pp 238-240, 1968. 



77 



APPENDIX V 

LIST OF PESTICIDES SUSPECTED OF CAUSING TUMORS 
Pesticide 



Maneb 

Zineb 

Inorganic bromides resulting from soil 
treatment with ethylene dibroi^ide 
Inorganic bromides resulting from fumigation 
^^^:^m\\\\ ethylene di bromide 

Piperonyl butoxide 

Mai 61 c hydrazide 

Calcium Arsenate 

Lead Arsenate 

Sodium Arsenate 

Inorganic bromides resulting from soil 
treatment with 1, 2-dibromo-3-chloropropane 

10. 180.198 Dimethyl (2,2,2-triochloro-l-hydroxethyl ) 

phosphonate 

11. 180.204 Dimethoate including its oxygen analog 

12. 180.217 Ammoniates for [ethyl enebis-(dithiocarbamato)] 

zinc and ethyl enebis [dithiocarbamic acid 
bimolecular cyclic anhydrosul fides and 
disulfides 

13. 180.235 2,2 - Dichlorovinyl dimethy phosphate 

14. 180.246 Daminozide 

15. 180.277 S-2,3 - Dichloroallyl diisopropylthiocarbamate 

16. 180.289 Methanearsonic acid 

17. 180.311 Cacodylic acid 

18. 180.317 3,5 - Dichloro - N - (1,1 - dimethyl-2 

-propynl ) benzami de 

19. 180.335 Sodium arsenite 



The above list of pesticides was taken from a list that GAO gave to FDA 
subsequent to GAO's February 14, 1978, testimony. 



CFR Reference 
(Title 40) 


1. 


180.110 


2. 


180.115 


3. 


180.126 




180.146 


4. 


180.127 


5. 


180.175 


6. 


180.192 


7. 


180.194 


8. 


180.196 


9. 


180.197 



78 



APPENDIX VI 



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«0 C *+- T- 






•4-> T- 






E E •— 






*o <o to 






4J 0)1— 






C E< 






O) 






c -0 






*o a; • 






-0 5^ tt> >> . 






S- t/) ^ iO 






J- 3 C 3 C 






u 10 






t— J- -M t. f- 






.C <U -M (U tn 






<J E E-»- 






U 3 






•f- M- -00 






<4- C —1 






«o 


E 




•/>«/» C 


QJ 




q; Qi co^—t- 


4-> 




J_ J- 1— c 


VI 




3 3 r- -D 


>, 




Nl N fO 4-> OJ 


CO 




T- •»- U CO tt> 






W QJ 0) >,*♦- 


-M 




V) CO U CO 


c 




•r- -0 


i 


CO 


po vn o) 


r»«. 


p— 00 vO •^J 


QJ 


^>. 


-D 10 


a> 


CO 


trt V) irt c C 


re 


CVJ 


(U O) O) «o T- 


c 




-0 XJ "O E 


re 


CJ 


3 3 3 CO re 


r: 




f— r— r— Z *-> 






u u u c 


E 




c c c 0- 


re 




•— ^- •— •• — 


en 



t 


•)c 


L. 




* * 


Q. 


1 


«•)(-)( 


4- 





79 



FY 1975 



SEIZURES 



PMS 05 Chemical Contamination (Human Foods) 
SAMPLE NO. 



21-642 H 
10-130 H 
19-517 H 
59-541 H 
10-131 H 
10-126 H 
DI 43-502 H 
53-415 H 
19-539 H 
70-366 H 
28-326 H 

95-082 H 
91-885 H 
113-614 H 
73-971 H 
114-059 H 

80-983 H 
20-882 H 

4-697 H 
10-127 H 
54-581 H 
69-703 H 
84-534 H 
89-387 H 
90-271 H 
90-272 H 
90-274 H 
90-649 H 
90-871 H 
108-619 H 
109-702 H 
DI 115-682 H 



PMS 01 - Animal Feed Safety 
SAMPLE NO . 

80-453 H 



PRODUCT 


CONTAMINAriT 


Radishes 


Dacthal 


Chubs, fresh 


Dieldrin 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Chubs, fresh 


Dieldrin 


Chubs, fresh 


Dieldrin 


Dinnerware, silverplated 


Lead 


Coffee Set 


Lead 


Potatoes 


Chlordane 


Radishes 


Dacthal 


Coho Salmon, canned 


Polychlorinated 


. 


Biohenyls 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Potatoes, fresh white 


Chlordane 


Wheat 


Malathion 


Coffee Beans 


Sodium Aluminum 




Fluoride 


Barley 


Malathion 


Salmon 


Polychlorinated 




Bi phenyls 


Potatoes 


Chlordane 


Chubs, fresh 


Dieldrin 


Soybeans 


Ronnel 


Potatoes 


Chlordane 


Noodles 


Diazinon 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Potatoes 


Chlordane 


Navy Beans, Michigan 


Methyl bromide 


Swordfish, frozen 


Mercury 


Cheese, Feta 


Hexachlorobenzene 


PRODUCT 


CONTAMINANT 


Veg. Oil (Ultra Fat) Veg. 


Dieldrin 



80 



FY 1975 



RECALLS 



PMS 05 Chemical Contamination (Human Foods) 




RECALL NO 


PRODUCT 


CONTAMINANT 


F-012-5 


Silverplated Bafay Cups (India) 


Leachable Lead 


F-028-5 


Stainless Steel Electric Kettle 


Leachable Lead 


F-029-5 


Canned Evaporated Milk 


Polybromated 
Biphynels (PBB) 


F-031-5 


Electric Teakettles 


Leachable Lead 


F-038-5 


Burdock Root 


Atropine 


F-084-5 


Silverplated Baby Cups (India) 


Leachable Lead 


F-090-5 


Canned Fruit Cocktail 


Sodium Sulfite 


F-m-5 


Potato Chips 


Hydrocarbons 


F-n4-5 


Soya-Lecithin Capsules 


Hexane 


F-132-5 


Carmel Danish Rolls 


Alergic Rections 




• 


Brazil Nuts Not 
Declared on Label 


F-142-5 


Corn Chips, Potato Chips, 


Alkaline 




Tortilla Chips & Cheese Puffs 


Crystals 


F-146-5 


Sweet Cream Butter 


Labeling Ink on 
Wrapper 


F-154-5 


Rice on 


Malathian 


PMS 01 Animal 


Feed Safety 




RECALL 


PRODUCT 


CONTAMINANT 


V-002-5 


Feed Supplement Blocks 


Dieldrin 



to 



81 



SEIZURES 

PMS 05 Chemical Cont2 
SAMPLE NO . 

76-336 H 

76-06-700 
76-28-651 
76-32-993 
76-53-186 



; ^ :'j/c 



■i nation (Human Foods) 
PRODUCT 

Fish Oil 



Swordfish 
Lettuce 
Yellow Grease 
Frozen Halibut 



CONTAMINANT 

Polychlorinated 

Biphenyls 

Mercury 

Methyl 3 

Endrin 

Mercury 



CITATIONS 

PMS 05 Chemical Conts=:ni nation (Human Foods 
PRODUCT 

Swordfish 

PMS 01 Animal Feed S^=T«ty 

PRODUCT 

Cottonseed Meal 
(2 Citation-) 



CONTAMINANT 
Mercury 

CONTAMINANT 

PCNB, Disyston, 
Chloroneb & Mercury 



RECALLS 

PMS OJ. Chemical Contrail nan ts (Human Foods) 

PRODUCT 

Beer 

Frozen popsicles 

Fresh Parsley 

Cocktail vegetable juice 

Rice Pudding 

Sharp Cheddar Cheese 

Vinyl Coated Aluminum 

Casserole Dish 



RECALL NO. 


F-003-6 


F-020-6 


F-029-6 


F-027-6 


F-069-6 


F-091-6 


F-134-6 



CONTAMINANT 

Chlorinated Phenols 

Calcium Chloride 

Para th ion 

Tin 

Soapy Taste 

Toluene 

Vinyl coating 



82 



FY 1975 



RECALLS 



PMS 01 Animal Feed 


Safety 




RECALL NO. 


PRODUCT 


CONTAMINANT 


V-013-6 


Feed Supplement with 
Magnesium Oxide 


Molybdenum 


V-015-6 


Bulk Animal Feed 


Lead 


V-017/021-6'^ 


60 Related Recalls of Animal 


Mercury 


V-022/039-6 ( 


Feeds With Cottonseed 


Disyston 


V-041/057-6 > 


Meal 


PCNB 


V-059/073-6 ( 




Malathian 


V-074/078-6J 




Methoxychlor 
Chloroneb 
HCB 
Captan 


V-083-6 


Mineral Feed Supplement 


Lead and Arsenic 


V- 08*4- 6 1 
V-091/095-6J 


6 Related Recalls of Feed 


Molybdenum 


with Magnesium Oxide 




V-102/121-61 
.V-124/128-6J 


25 Related Recalls 


Heotachlor 


- of Animal Feeds 


and Trans Chlordane 



83 



FY 77 



SEIZURES 



PMS 05 Chemical Contaminants (Human Foods) 
SAMPLE NO. PRODUCT 



76-43-266 


Swordfish 


77-43-741 


Swordfish 


77-43-414 


Swordfish 


77-12-577 


Swordfish 


77-78-340 


Swordfish 


77-78-336 


Swordfish 


77-91-555 


Swordfish 


77-42-670/1 


Swordfish 


77-14-482 


Swordfish 


77-91-278 


Swordfish 


77-89-706 


Swordfish 


77-59-663 


Swordfish 


77-59-667 


Swordfish 


77-89-506 


Swordfish 


77-97-713 


Mahi Mahi Fillets 


77-10-384 


Halibut 


77-71-557 


Halibut 


77-53-464 


Halibut 


77-70-540 


Halibut 


77-72-089 


Halibut 


77-72-098 


Halibut 


77-72-095 


Halibut 


77-17-681 


Halibut 


77-72-091 


Halibut 


77-72-094 


Halibut 


77-52-909 


Halibut 


77-03-884 


Halibut 


77-31-056 


Wheat 


77-30-516/20^ 
77-30-526/27J 


Mass Seizure 


Multiple Foods 


77-26-382/83 


Wheat 


77-49-295 


Rice 


77-50-356 


Mung Beans 



CONTAMINANT 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Mercury 

Potassium Chloride 

Pesticide 

Mercury 

Diazinon 

Endrin 



PROSECUTION 

PMS 05 Chemical Contaminants CHuman foods 1 

PRODUCT 

Swordfish 



CONTAMINANT 



Mercury 



84 



FY 77 



PROSECUTION 

PMS 01 Animal Feed Safety 

, PRODUCT 

Cottonseed Meal 
(2 Prosecutions) 



CONTAMINANT 

PCNB, Disyston 
Chloroneb & Mercury 



CITATION 

PMS 05 C henical Contaminants (Human Foods] 

PRODUCT 

Swordfisft 



CONTAMINANT 
Mercury 



INJUNCTIONS 

PMS 05 C hemical Contaminants (Human Foods) 

PRODUCT 

Swordfish • 
(2 Injuctions) 



CONTAMINANT 



Mercury 



RECALLS 

PMS 05 Chemical Contaminants CHuman Foods) 
RECALL NO. PRODUCT 



CONTAMINANT 



F-014-7 


Grapefruit Juice, canned, 
sweetened 


Can detinning 


F-046-7 


Dinners and Foods, frozen 


Ammonia 


F-047-7 


Beer, Michelob 


Inner coating (Lac- 
quer) blistering 


F-051-7 


Pretzels 


Sodium Hydroxide 


F-125-7 


7 UP Carbonated beverage 


Chemical (Aliph- 
atic Hydrocarbon 
and Mineral spirits) 


F- 133-7 


MahT Mahi Fish, Frozen 


Histamine 



85 
APPENDIX VII 




UNITED STATES GENERAL ACCOUNTING OFFICE 
WASHINGTON. D.C. 20548 



February 24, 1978 



Mr. Pichard A. Heller 

Counsel 

Subcommittee on Oversight and Investigations 

Committee on Interstate and Foreign Commerce 

House of Representatives 

I Dear Mr. Heller: 

■j At your request we are providing information relating to conclusions 
in our testimony that FDA should expand its residue testing program. 

Total Diet Study 

We do not consider FDA's total diet study an appropriate substitute 
for FDA's pesticide surveillance program because a dozen or more foods are 
blended together in slurries wtiich are then analyzed for residues; violative 
pesticide residues in a particular food product could often escape detection. 

Further, although the total diet study does test for some heavy metals, 
it uses the same multiresidue detection methods as FDA's pesticide surveillance 
program and, therefore, it will provide information on the same pesticides 
detected in the surveillance program. As we have previously noted, only up 
to 107 of the 268 pesticides for which tolerances have been set will be detected 
if all six FDA multiresidue methods are used. In addition, the total diet 
study is an information gathering program and does not serve as a basis for 
regulatory action. FDA's Deputy Associate Commissioner for Compliance has, 
in the past, informed us that this program is not intended to be statistically 
valid or representative of the typical diet of the general population. 

Tolerance Violation Rate 

Our comments regarding FDA's 3 percent pesticide violation rate were 
based on information provided to GAG by FDA. FDA discussed this point in 
its letter commenting on our draft report. The letter stated: 

"Additionally, we do not believe that the recommended action is 
commensurate with the relative seriousness of pesticide residues 
in food. Each year, FDA samples about 7000-8000 shipments of food 
and feed for pesticide residues. As indicated in the GAG report, 
less than 3 percent of these shipr.ents contain residue levels 
in excess of established tolerances. The incidence of pesticide 
residues in most raw agricultural commodities is generally of a 
low order and their levels are frequently well below established 
* tolerances." 



86 



As can be seen, there is no reference that the rate of violation pertains to 
other than pesticide residues in excess of established tolerance levels. 
In discussion with FDA officials during February 1978, we were told that the 
rate of pesticide violations was 3.1 percent for the objective sampling 
program and 6.8 percent for sampling based on local intelligence. 

At your request we reviewed FDA's computer printout of the; approximately 
6,400 domestic food samples analyzed during FY 1977. We fourid that FDA's 
various district offices reported that 198 (3.1 percent) of the approximately 
6,400 samples examined were violative. Of the 198 samples, 106 (1.7 percent 
of the total) contained violative levels of pesticides or their metabolites 
or decomposition products — levels which exceeded either established toler- 
ances or FDA administrative guidelines or action levels. Additionally, 32 
of the 106 that contained violative levels of pesticides also contained 
violative levels of other contaminants such as mercury or PCB. The remaining 
92 violative samples which did not contain reported violative levels of pesti- 
cides were violative t>ecause of heavy metal (mercury, lead, cadmium) or 
industrial waste (PCB, HCB) contamination. 

Although the 1.7 percent pesticide violation rate is less than FDA 
told us originally, we still believe the rate is significant, particularly 
because FDA checks for only about 25 percent of the pesticides with tolerances. 
We continue to believe that FDA's program should be expanded so that all pesti- 
cide with tolerances are periodically sampled. It also appears appropriate 
that FDA sample more frequently for those pesticides suspected of causing 
adverse effects such as cancer or other tumors, birth defects, etc. 

Methods Used by FDA in 
Surveillance Program 

In our testimony, we stated that FDA's most used multiresidue method 
does not identify 20 pesticide chemicals suspected of causing cancer or other 
tumors. I^iese 20 chemicals have 612 individual tolerances. Because this 
multiresidue method is used up to 80 percent of the time, these chemicals 
will not be monitored up to 80 percent of the time in FDA's pesticide 
surveillance program. We believe that chemicals with potential to cause 
cancer and other tumors should be monitored more frequently than this. 

In a January 1978 letter, FDA said that it could not tell us either the 
number of times each multiresidue method was used in its surveillance program 
or the results of all of its specialized pesticide surveys conducted during 
FY 1977. (See pages 2 and 3 of Enclosure I.) In our testimony we cited all 
of the special surveys on which FDA provided us information and provided the 
Subconmittee a list of these special FY 1977 surveys. (See Enclosure II.) 



87 



At your request we asked FDA about its monitoring of these 20 suspect 
chemicals. An FDA official told us that FDA has tested or will test for 
residues of 12 of the 20 suspect chemicals. He said residues of seven were 
tested for in the total diet study which, as we have previously noted, does 
not form the basis for regulatory action. He said two others are detected by 
a method available for use in the compliance program, however, he could not 
tell us how many tests were performed using this method and we noted that 
use of the cited method was not required in the FY 1977 compliance program. 
He said residues of two others will be detected in the ETU special survey 
that was begun in FY 1977. The twelfth chemical will be tested for in an 
FDA special survey planned for FY 1978. 

We continue to believe that it is not sufficient for FDA to place 
reliance in a pesticide surveillance program that tests for only 25 percent 
of the residues for which tolerances have been set. In a similar vein, we 
believe that little reliance can be placed in the total diet study to identify 
violative levels of pesticide on individual food commodities when up to a 
dozen or more foods are blended together and tested as one product. 



We trust that the foregoing satifies your needs. We will be happy, 
however, to provide any. additional information that you may find necessary. 

Sincerely yours. 



li-CAyiAyidu.^^/ 



Henry Eschwege 
Director 



Enclosures- 2 — l^crr'pRiwrep 



88 



APPENDIX VIII 

li:t of ajcimal tmcs, 
pesticides, a.nd entiron'ment.^x ccnt/j:ina!,ts 

WHICH MAY RESULT IN RESIDUES IN 
RAW MEAT AND POULTRY 4t 

A) Included in USDA monitoring (24 out of 47 drugs and pesticides 

have adequate methods 

Animal drugs (3 of 26 have detection methods for 
regulatory purposes (m)) 

nj 1) Arsenic 

2) Carbadox 

3) Chlortetracycline 

4) Clopidol 

5) Decoquinate 

6) Dichlorvos 

7) Diethylstilbestrol 



8) Erythromycin 

9) Ipronidazole 

10) Levamisole hydrochloride 

11) Monensin 

12) Neomycin 

13) Oxytetracycline 

14) Penicillin 

15) Robenidine hydrochloride 

16) Streptomycin 

17) Sulfachlorpyridazine 

18) Sulfadlmethoxine 

19) Sulfaethoxypyridazine 

20) Sulfamethazine 

21) Sulfanitran 



89 



A) Included in USDA monitoring 
Animal drugs 

22) Sulfathiazole 

23) Sulfomyxin 

24) Tetracycline 

25) Thiabendazole 
m 26) Zeranol 

Pesticides (21 of 21- have adequate methods) 

m 27) Aldrin 

I 
m 28) Benzene Hexachloride 

m 29) Chlordane 

m 30) Coumaphos 

m 31) DDT ': 



m 32) Dlazinon 

m 33) Dieldrin " 

m 34) Dioxathion 

m 35) Endrin 

m 36) Ethion 

tn 37) Gardona 

m 38) Heptaohlor 

m 39) Lindane 



90 



>) Ir.clucfcd in USPA rcr.itoring, 
Pesticides 
m 40) Malathion 
m 41) Methoxychlor 
m 42) Methyl Parathion 
m 43) Mirex 
m 44) Parathion 
m 45) Rotmel 

m 46) Toxaphene 
m 47) Trichlorofon 

Envlrormental contaminants 

48) Cadmium 

49) Copper 

50) Hexachlorobenzene 

51) Iron 

52) Lead 
53) -Mercury 

54) Polybrominated biphenyls 

55) Polychlorinated biphenyls 



91 



B) Not Included in USDA monitoring (35 of .97 have adequate methods) 
Animal drugs (3 out of 41 have adequate methods) 

1) 2-Acetylamino-5-nitrothiazole 

2) Alkomide 

m 3) Ampicillin 

4) Amprolium 

5) Bacitracin 

6) Buquinolate 

7) Carbomycin 

8) Cephapirin 

9) Chlorhexadine 

10) Chlormadinone acetate 

11) Cloxacillin 

12) Dihydrostreptomycin 

13) Dimetridazole 



92 



) Not included in USTA r-.or.itoring, 
Animal drugs 

14) 3,5-Dinitroben^amide 

15) Estradiol benroate 

16) Estradiol monopalmitate 

17) Ethopabatc 

,18) Furazolidone 

19) iCentamicin sulfate 

20) Gentian violet ;. 

2^> Haloxon 

22) - Hygromycin B 

23) Lasalocid sodium 
in 24) Lincomycin 

m 25) Melengestrol acetate 

26) Metoserpate hydrochloride 



27) Nequinate 

28) Novobiocin 

29) Nystatin 

30) Oleandomycin 

31) Ormetoprim 

32) Progesterone 

33) Pyrantel tartrate 

34) Reserpine 



93 



B) Not included in L'SDA monitoring 

Animal drugs 

35) Sodium sulf achloropyrazine 

monohydrate 

36) Spectinomycin 

37) Testosterone 

38) Testosterone propionate 

39) Tylosin 

40) Virglniamycin 

41) Zoalene 

Pesticide^. (32 out of ,56 have adequate Methods) 

m 42) Acephate ^ '. 

m 43) Aldicarb \ 

m - ^/ Atrazine 

^^) Azinophosmethyl j 

m ^6) Benomyl 

m 47) sec-Butylamine 

m ^®^ Captan 

m 49) Carbaryl 

m 50) Carbofuran 

m 51) Carbophenothion 

m 52) Chlordimeform 



94 



) Net included in USDA rr.onitorir.^, 
Pesticides 

m 53) Chlorobenzllate 

m 54) Chlorpyrifos 

m 55) Crufomate 

m 56) 2,A-D 

m 57} Dalapon 

m 58) Daminozide 

59) Def 

60) Demeton 

m 61) Dialifor 

m 62) Dimethoate 

63) Diphenyl amine 

6^) Disyston 

65) Diuron 

66) Dodine 

m 67) Endosulfan 

m 68) Fen th ion 

69)^ Fleam 

■ 

70) Guthion 

m 71) Hexakis 

72) Linuron 

73) Maneb 

'^) Methanearsonic acid 

m 75) Methoprene 

76)i Naled 



95 



E) Not included in USDA ncnilorinc, 

Pesticides 
m 77) Paraquat 

78) Pentachlorophenol 

79) Perthane 
m 80) Phorate 

m 81) Phosolone 

m 82) Piperonyl butoxide 

83) Plictran 

84) Poly ram 

85) Propachlor 
m 86) Propargite 
m 87) Pyrethrins 

88) Sencor 
ni g9) Silvex ^ 

™ 90) Simazine 

91) Stam 
m 92) 2,4, 5-T \ZZ' 

93) Terbacil 
m 94) TDE 

95) ' Tetradifon 

95) Zinc ion and maneb 

coordination product 



97) Zineb 



96 



APPENDIX IX 




LATION RATES, 


AS DETECTED BY USl 




Table 1 ^ 




Species 




Violation rate 


Cattle 


14.96 


Calves 




8.84 


Sheep and Goats 




2.60 


Swine 




15.83 


Horses 




6.71 


Chickens 




5.08 


Turkeys 




8.46 


Ducks and Geese 




12.51 


Rabbits 


\^^^ 


6.64 



^Vw^SUSL -^ 







97 



Table 2 



Pesticides 


Samples Analyzed 


Samples Violative 


Percent Violativ. 


Chlorinated 

hydrocarbons £/ 


1353^ 


232 


1.71 


Organophosphates 


800 


3 


.38 


Animal drugs 








Antibiotics 


12420 


436 


3.51 


» Arsenic 


6986 


69 


.99 


^ Diethylstllbestro 


1 7502 


47 


.63 


Zeranol 


249 







Zearolinone 


250 







> Sulfas 


8016 


300 


3.74 


Clopidol 


382 





0.00 


Monensin 


910 


1 


0.11 


• Carbadox 


2148 


13 


0.61 


Thiabedazole 


149 





0.00 


Levamisole 


4 





0.00 


Decoquinate 


97 





0.00 


Robenadine 


763 


9 


1.18 


* Ipronidazole 


820 


17 


2.07 


Environmental contaminants 






Mercury, cadmium, 
copper 


lead, 

2414 


34 


1.41 


Iron 


178 





0.00 


PBB 


39 





0.00 




57,661 


1161 





£/ Includes the environmental contaminants polychlorined biphenyls and 
hexachlorophene . 

10 



98 



APPENDIX X 

ANIMAL DRUGS AND PESTICIDES 
SUSPECTED OF CAUSING CANCER OR BIRTH DEFECTS 



I Cancer 



a) Animal drugs included in USDA monitoring 
m 1) Arsenic 

2) Carbadox 

3) Diethylstilbestrol 

4) Ipronidazole 

5) Sulfamethazine 

6) Sulfathiazole 

B) Animal drugs not included in USDA monitoring 

7) Chlormadinone acetate 

8) Dimetridazole 

9) Estradiol benzoate 

10) Estradiol monopalmitate 

11) Furazolidone 

12) Gentian violet (not an approved animal drug but 

reported as being used.) 

13) Melengestrol acetate 

14) Progesterone 

15) Testosterone 

C) Pesticides included in USDA monitoring 
m 1) Aldrin 

m 2) Benzene hexachloride 

m 3) Chlordane 

m 4) DDT 

m 5) Dieldrin 



99 



,>^ 6) Endrin 

m 7) Heptachlor 

m 8) Lindane 

m 9) Mirex 

m 10) Ronnel 

m 11) Toxaphene 

m 12) Trichlorofon 
D) Pesticides not included in USDA monitoring 

m 13) Captan 

tn 14) Carbaryl 

m 15) Chlorobenzilate , 

m 16) Dimethoate 

17) Maneb 

18) Perthane 

m 19) Piperonylbutoxide 

20) Poly ram 

m 21) Silvex 

m 22) 2,4-5-T 

m 23) TDE 

24) ZincAon and maneb coordination product, 

25) Zineb 

II Birth Defects 

A) Animal drugs included in the monitoring program 

None 

B) Animal drugs not included in the monitoring program 

1) Chlormadinone acetate 

2) Reserpine 

C) Pesticides included in the monitoring program 
m 1) Ronnel (based on dioxin contaminant) 



nj 2) Endrin 
m 3) Trichlorofon 



100 



D) Pesticides not included in the monitoring program 
m 1) Cap tan 
m 2) Carbaryl 
m 3) 2,4-D 

A) Demeton 

5) Diphenyl amine 
m 6) Fen th ion 

7) Maneb 
m 8) Paraquat 

9) Pentachlorophenol (photodegrades to dioxin) 
m 10) Silvex (based on dioxin contaminant) 
m 11) 2,4, 5-T (based on dioxin contaminant) 

12) Zineb 
m 13) Benomyl 



APPENDIX XI 

Glossary op Terms 

CPSC — Consumer Product Safety Commission 

EPA — Environmental Protection Agency 

FDA — Food and Drug Administration 

GAO — General Accounting Office 

NIOSH — National Institute of Occupation Safety and Health 

OSHA — Occupational Safety and Health Administration 

USD A — U.S. Department of Agriculture 

FFDC A— Federal Food, Drug, and Cosmetic Act 

FIFRA — Federal Insecticide, Fungicide and Rodenticide Act 

Toxica 
Acute toxicity: adverse effects from a single dose. Mortality in 50 

percent of the animals exposed 
Subacute Toxicity: adverse effects from repeated exposure over a 

short period of time, usually 90 days 
Oncogenicity : power of a substance to incite tumor formation, either 

benign or malignant in living tissue 

ability to induce tumors 
Teratogenicity: ability of a substance to induce birth defects by acting 

on the embryo 
Teratogenic : quality of a substance to induce birth defects by acting 

on the embryo 
Mutagenic: quality of substance to i)roduce permanent, hereditary 

genetic changes 
Mutagenicity: power of a substance to produce permanent, hereditary 

genetic changes. Genetic mutations may not be apparent for 

generations 
Chronic feeding-oncogenicity : chronic feeding over most of test ani- 
mals' lifetimes to determme whether substance induces growth of 

tumors 
Reproduction: testing to determine whether a substance causes 

adverse effects on animals' abilities to reproduce: size and health of 

offspring, effects on fertility 
Teratogenicity : testing to determine whether a substance causes birth 

defects 
Mutagenicity : testing to determine whether substance causes genetic 

changes that will be passed on to future generations 
Pesticides : pest killers 

herbicides: weed killers 

fungicides: mold, mushroom, mildew, and rust destroyers and 
repellants 

insecticides: insect killers 

(101) 



102 

USD A Programs: 
Random Sample Monitoring Program: analyzes tissue samples 

from a percentage of randomly selected animal carcasses in 

slaughterhouses 
Pretest Program: enjoins growers who have shipped animals with 

above-tolerance levels of pesticides or animal drugs to market in 

the past, to provide the department with laboratory analyses of 

livestock samples prior to slaughter 
Hold and test 
Surveillance 

Adultered: chemically contaminated 
Carcinogens: cancer causers 

Inert: substance does not have active pesticide properties 
Suspect carcinogens: See Inert definition above 

Violative: containing illegal levels of chemical residues (meat prod- 
ucts, animals) 
Market Basket Survey: analyzes typical total diet 
Pesticide tolerances for raw agricultural commodities: maximum 

amounts of active pesticide ingredients that may be legally present 

in or on particular foods and animal feeds. EPA establishes under 

terms of FFDCA. 

Action levels : 
Legal limits for chemicals which cannot be lawfully used on food or 

animal feed crops, but are present in the environment and therefore 

show up as residues in food. 
Legal amounts of chemical residues that may be present in foods for 

which no tolerances have been established. 
Established tolerance: maximum amount of a chemical that may be 

legally present in a particular commodity. 
Residue: amount of a pesticide remaining in or on food following 

normal product use. 

Potential exposure: 
Total potential daily exposure : based on all tolerances that have been 

set for that pesticide and an average daily diet estimate for an 

American male. 
Acceptable daily exposure: level of total potential daily exposure 

below which exposure considered safe. 

Permissible exposure is calculated from the following information : 

( 1 ) NOEL— No Observable Effect Level 

Level of a substance administered to a group of experimental 
animals at which those adverse effects observed or measured 
at higher levels are absent. 

Rats or mice are usual test animals. 

NOEL expressed in parts j)er million (ppm) and converted to 
milligrams per kilogram of body weight per day (mg/kg/day). 

(2) Safety Factor or ''Factor of 100" 

Rationale for using 100. Man appears to be 10 times as sensitive 
to toxic substances as the rat and sickness increases the sus- 
ceptibility of man to such substance 10 times. 
(:^) ADI: Acceptable Daily Intake 
ADI±=NOEL 

Safety Factor 



103 

(4) MPI: Maximum Permissible Intake 

MPI = ADIXAverao:e weight of an adult (i.e., Average \vt. of an 
a(lult = 60 kg=132 lbs.). 
TMRC: Theoretical Maximum Residue Contribution 

Maximum potential exposure 
TMRC = Proposed tolerance X Food factor X Daily diet. 
Food Factor: Estimate of how much of the commodity to be treated 
with the pesticide will be eaten daily by the average American 
(based on average consumption for the total population). 
Daily Diet: 1500 grams (3.3 pounds). 

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